PMCF Study on PEEK Suture Anchors for Shoulder Indications
Sponsor
Smith & Nephew, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03826667
Collaborator
(none)
464
11
6.4
42.2
6.6
Study Details
Study Description
Brief Summary
Post-market clinical follow-up on the PEEK Suture Anchors in the shoulder.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
464 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Post-market Clinical Follow-up (PMCF) Study on PEEK Suture Anchors for Shoulder Indications
Actual Study Start Date
:
Feb 14, 2019
Actual Primary Completion Date
:
Aug 28, 2019
Actual Study Completion Date
:
Aug 28, 2019
Outcome Measures
Primary Outcome Measures
- Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention [6 months]
Clinical success was defined as shoulder repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered "Yes" based on the following 3 main criteria: no inflammatory or allergic response no device-related adverse event (AE) no device deficiencies (DDs) leading to revision surgery (re intervention) on the index shoulder
Secondary Outcome Measures
- Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention [12 months]
Clinical success was defined as shoulder repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered "Yes" based on the following 3 main criteria: no inflammatory or allergic response no device-related adverse event (AE) no device deficiencies (DDs) leading to revision surgery (re intervention) on the index shoulder
- Visual Analog Scale (VAS) - Pain [6 and 12 months]
The VAS is a continuous scale comprised of a horizontal line 100 millimeters (mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. The VAS pain score is presented on a scale ranging from 0 to 10. A score of 0 represents no pain (0 mm) and a score of 10 indicates extreme/unbearable pain (100 mm). The VAS rating was recorded retrospectively, per standard of care at 6 and 12 months post-surgery.
- Count of Participants With Range of Motion (ROM) Full Functional Arc [6 and 12 months]
Range of motion defined as the participant having a full functional arc "Yes" or "No" at 6 month and 12 month post-operative visits.
- Range of Motion (ROM) [6 and 12 months]
Forward flexion angle, internal rotation angle, and external rotation angle captured in degrees based on physician's Standard of Care.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subjects who have undergone shoulder joint repair using the study devices.
-
Subjects aged 18 years and older at the time of surgery.
Exclusion Criteria:
-
Subjects who are < 12 months post-operative.
-
Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 30 days prior to surgery.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Grandview Medical Center | Birmingham | Alabama | United States | 35242 |
| 2 | OrthoArizona | Phoenix | Arizona | United States | 85018 |
| 3 | University of Colorado- Denver | Denver | Colorado | United States | 80222 |
| 4 | Holy Cross Hospital/Orthopedic Institute | Fort Lauderdale | Florida | United States | 33334 |
| 5 | OrthoAtlanta | Lawrenceville | Georgia | United States | 30046 |
| 6 | Community Hospital | Oklahoma City | Oklahoma | United States | 73114 |
| 7 | University Orthopedics Center | Altoona | Pennsylvania | United States | 16602 |
| 8 | Houston Methodist at Baytown | Baytown | Texas | United States | 77521 |
| 9 | Texas Orthopedic Hospital - Houston | Houston | Texas | United States | 77030 |
| 10 | Aspen Orthopedics at New Berlin | New Berlin | Wisconsin | United States | 53151 |
| 11 | Aspen Orthopedics at West Allis | West Allis | Wisconsin | United States | 80222 |
Sponsors and Collaborators
- Smith & Nephew, Inc.
Investigators
- Study Chair: Judth Horner, Smith & Nephew, Inc.
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Smith & Nephew, Inc.
ClinicalTrials.gov Identifier:
NCT03826667
Other Study ID Numbers:
- 2018.16.SMD.PEEK.RET.SHD
First Posted:
Feb 1, 2019
Last Update Posted:
Apr 12, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | It was intended to enroll participants for 8 PEEK suture anchor devices; however, no participants were enrolled for the BIORAPTOR™ Knotless Suture Anchors, resulting in 7 suture anchor groups being analyzed. A total of 464 participants were enrolled in the study and 467 joints were observed. Multiple devices were implanted in 124 participants. |
| Arm/Group Title | Polyetheretherketone (PEEK) Shoulder Suture Anchors |
|---|---|
| Arm/Group Description | Participants who have received PEEK Suture Anchors in the shoulder which included: HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device |
| Period Title: Overall Study | |
| STARTED | 464 |
| HEALICOIL™ PK Preloaded Suture Anchors | 193 |
| BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors | 41 |
| MULTIFIX™ S Ultra Knotless Fixation System | 78 |
| FOOTPRINT™ Ultra PK Suture Anchors | 136 |
| TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and With Needles | 57 |
| SPEEDSCREW™ Knotless Fixation System | 59 |
| SpeedLock Knotless Fixation Device | 18 |
| COMPLETED | 443 |
| NOT COMPLETED | 21 |
Baseline Characteristics
| Arm/Group Title | Polyetheretherketone (PEEK) Shoulder Suture Anchors |
|---|---|
| Arm/Group Description | Participants who have received PEEK Suture Anchors in the shoulder which included: HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device |
| Overall Participants | 464 |
| Overall joints | 467 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
54.00
(14.10)
|
| Sex: Female, Male (joints) [Count of Units] | |
| Female |
190
|
| Male |
277
|
| Ethnicity (NIH/OMB) (joints) [Count of Units] | |
| Hispanic or Latino |
30
|
| Not Hispanic or Latino |
367
|
| Unknown or Not Reported |
70
|
| Race/Ethnicity, Customized (joints) [Count of Units] | |
| No |
462
|
| Yes |
5
|
| No |
464
|
| Yes |
3
|
| No |
444
|
| Yes |
23
|
| No |
465
|
| Yes |
2
|
| No |
94
|
| Yes |
373
|
| No |
403
|
| Yes |
64
|
| Region of Enrollment (joints) [Number] | |
| United States |
467
|
| Location of Device Implantation (joints) [Count of Units] | |
| Left Shoulder |
194
|
| Right Shoulder |
271
|
| Bilaterally |
2
|
| Duration of Surgery (minutes) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [minutes] |
99.2
(50.7)
|
| Duration of time from injury to surgery (days) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [days] |
405.7
(929.2)
|
| Any Medical History (joints) [Count of Units] | |
| Yes |
392
|
| No |
75
|
| Number of Participant Joints Treated by Indication (joints) [Count of Units] | |
| Bankart lesion repair |
12
|
| SLAP lesion repair |
2
|
| Capsular shift |
5
|
| Rotator cuff repair |
413
|
| Biceps tenodesis |
33
|
| Other |
2
|
| Disposition of Suture Anchors (Count of Participants) | |
| HEALICOIL™ PK Preloaded Suture Anchors |
193
41.6%
|
| BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor |
41
8.8%
|
| MULTIFIX™ S Ultra Knotless Fixation System |
78
16.8%
|
| FOOTPRINT™ Ultra PK Suture Anchor |
136
29.3%
|
| TWINFIX™ Ultra PK Suture Anchor |
57
12.3%
|
| SPEEDSCREW™ Knotless Fixation System |
59
12.7%
|
| SpeedLock Knotless Fixation Device |
18
3.9%
|
Outcome Measures
| Title | Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention |
|---|---|
| Description | Clinical success was defined as shoulder repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered "Yes" based on the following 3 main criteria: no inflammatory or allergic response no device-related adverse event (AE) no device deficiencies (DDs) leading to revision surgery (re intervention) on the index shoulder |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates combined total of distinct participants assessed. |
| Arm/Group Title | Polyetheretherketone (PEEK) Shoulder Suture Anchors |
|---|---|
| Arm/Group Description | Participants who have received PEEK Suture Anchors in the shoulder which included: HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device |
| Measure Participants | 458 |
| Yes |
185
39.9%
|
| No |
6
1.3%
|
| Yes |
38
8.2%
|
| No |
3
0.6%
|
| Yes |
71
15.3%
|
| No |
6
1.3%
|
| Yes |
128
27.6%
|
| No |
3
0.6%
|
| Yes |
57
12.3%
|
| No |
0
0%
|
| Yes |
58
12.5%
|
| No |
1
0.2%
|
| Yes |
18
3.9%
|
| No |
0
0%
|
| Title | Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention |
|---|---|
| Description | Clinical success was defined as shoulder repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered "Yes" based on the following 3 main criteria: no inflammatory or allergic response no device-related adverse event (AE) no device deficiencies (DDs) leading to revision surgery (re intervention) on the index shoulder |
| Time Frame | 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates combined total of distinct participants assessed. |
| Arm/Group Title | Polyetheretherketone (PEEK) Shoulder Suture Anchors |
|---|---|
| Arm/Group Description | Participants who have received PEEK Suture Anchors in the shoulder which included: HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device |
| Measure Participants | 85 |
| Yes |
50
10.8%
|
| No |
1
0.2%
|
| Yes |
5
1.1%
|
| No |
0
0%
|
| Yes |
17
3.7%
|
| No |
1
0.2%
|
| Yes |
16
3.4%
|
| No |
2
0.4%
|
| Yes |
6
1.3%
|
| No |
0
0%
|
| Yes |
4
0.9%
|
| No |
1
0.2%
|
| Yes |
2
0.4%
|
| No |
0
0%
|
| Title | Visual Analog Scale (VAS) - Pain |
|---|---|
| Description | The VAS is a continuous scale comprised of a horizontal line 100 millimeters (mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. The VAS pain score is presented on a scale ranging from 0 to 10. A score of 0 represents no pain (0 mm) and a score of 10 indicates extreme/unbearable pain (100 mm). The VAS rating was recorded retrospectively, per standard of care at 6 and 12 months post-surgery. |
| Time Frame | 6 and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates combined total of distinct participants assessed. |
| Arm/Group Title | Polyetheretherketone (PEEK) Shoulder Suture Anchors |
|---|---|
| Arm/Group Description | Participants who have received PEEK Suture Anchors in the shoulder which included: HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device |
| Measure Participants | 100 |
| HEALICOIL™ PK Preloaded Suture Anchors: 6 months |
1.8
(2.1)
|
| HEALICOIL™ PK Preloaded Suture Anchors: 12 months |
2.4
(1.8)
|
| BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: 6 months |
2.5
(2.8)
|
| BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: 12 months |
4.5
(0.7)
|
| MULTIFIX™ S Ultra Knotless Fixation System: 6 months |
2.2
(2.1)
|
| MULTIFIX™ S Ultra Knotless Fixation System: 12 months |
2.3
(1.9)
|
| FOOTPRINT™ Ultra PK Suture Anchor: 6 months |
2.3
(2.1)
|
| SPEEDSCREW™ Knotless Fixation System: 6 months |
1.4
(3.1)
|
| SpeedLock Knotless Fixation Device: 6 months |
0
(0)
|
| Title | Count of Participants With Range of Motion (ROM) Full Functional Arc |
|---|---|
| Description | Range of motion defined as the participant having a full functional arc "Yes" or "No" at 6 month and 12 month post-operative visits. |
| Time Frame | 6 and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates combined total of distinct participants assessed. |
| Arm/Group Title | Polyetheretherketone (PEEK) Shoulder Suture Anchors |
|---|---|
| Arm/Group Description | Participants who have received PEEK Suture Anchors in the shoulder which included: HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device |
| Measure Participants | 348 |
| Has full functional arc: Yes |
111
23.9%
|
| Has full functional arc: No |
48
10.3%
|
| Has full functional arc: Unknown |
4
0.9%
|
| Has full functional arc: Yes |
37
8%
|
| Has full functional arc: No |
10
2.2%
|
| Has full functional arc: Unknown |
2
0.4%
|
| Has full functional arc: Yes |
29
6.3%
|
| Has full functional arc: No |
3
0.6%
|
| Has full functional arc: Unknown |
1
0.2%
|
| Has full functional arc: Yes |
1
0.2%
|
| Has full functional arc: No |
1
0.2%
|
| Has full functional arc: Unknown |
0
0%
|
| Has full functional arc: Yes |
35
7.5%
|
| Has full functional arc: No |
12
2.6%
|
| Has full functional arc: Unknown |
4
0.9%
|
| Has full functional arc: Yes |
9
1.9%
|
| Has full functional arc: No |
7
1.5%
|
| Has full functional arc: Unknown |
0
0%
|
| Has full functional arc: Yes |
90
19.4%
|
| Has full functional arc: No |
14
3%
|
| Has full functional arc: Unknown |
1
0.2%
|
| Has full functional arc: Yes |
17
3.7%
|
| Has full functional arc: No |
2
0.4%
|
| Has full functional arc: Unknown |
0
0%
|
| Has full functional arc: Yes | |
| Has full functional arc: No | |
| Has full functional arc: Unknown | |
| Has full functional arc: Yes | |
| Has full functional arc: No | |
| Has full functional arc: Unknown | |
| Has full functional arc: Yes |
46
9.9%
|
| Has full functional arc: No |
5
1.1%
|
| Has full functional arc: Unknown |
3
0.6%
|
| Has full functional arc: Yes |
4
0.9%
|
| Has full functional arc: No |
1
0.2%
|
| Has full functional arc: Unknown |
0
0%
|
| Has full functional arc: Yes |
18
3.9%
|
| Has full functional arc: No |
0
0%
|
| Has full functional arc: Unknown |
0
0%
|
| Has full functional arc: Yes |
2
0.4%
|
| Has full functional arc: No |
0
0%
|
| Has full functional arc: Unknown |
0
0%
|
| Title | Range of Motion (ROM) |
|---|---|
| Description | Forward flexion angle, internal rotation angle, and external rotation angle captured in degrees based on physician's Standard of Care. |
| Time Frame | 6 and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates combined total of distinct participants assessed. |
| Arm/Group Title | Polyetheretherketone (PEEK) Shoulder Suture Anchors |
|---|---|
| Arm/Group Description | Participants who have received PEEK Suture Anchors in the shoulder which included: HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device |
| Measure Participants | 70 |
| HEALICOIL™ PK Preloaded Suture Anchors: Forward Flexion Angle (6 months) |
157
(20.2)
|
| HEALICOIL™ PK Preloaded Suture Anchors: Internal Rotation Angle (6 months) |
25.7
(40.6)
|
| HEALICOIL™ PK Preloaded Suture Anchors: External Rotation (6 months) |
49.3
(20.5)
|
| HEALICOIL™ PK Preloaded Suture Anchors Forward Flexion Angle (12 months) |
141.1
(39.8)
|
| HEALICOIL™ PK Preloaded Suture Anchors Internal Rotation Angle (12 months) |
75
(21.2)
|
| HEALICOIL™ PK Preloaded Suture Anchors External Rotation (12 months) |
59.4
(25.7)
|
| BIORAPTOR™ 2.3 PK /BIORAPTOR™ Curved 2.3 PK Suture Anchor: Forward Flexion Angle (6 months) |
89
(100.4)
|
| BIORAPTOR™ 2.3 PK /BIORAPTOR™ Curved 2.3 PK Suture Anchor: Internal Rotation Angle (6 months) |
60
(15)
|
| BIORAPTOR™ 2.3 PK /BIORAPTOR™ Curved 2.3 PK Suture Anchor: External Rotation (6 months) |
100
(30)
|
| MULTIFIX™ S Ultra Knotless Fixation System: Forward Flexion Angle (6 months) |
122.5
(39.4)
|
| MULTIFIX™ S Ultra Knotless Fixation System: Internal Rotation Angle (6 months) |
90
(NA)
|
| MULTIFIX™ S Ultra Knotless Fixation System: External Rotation (6 months) |
59.8
(25.3)
|
| MULTIFIX™ S Ultra Knotless Fixation System: Forward Flexion Angle (12 months) |
141.7
(38.2)
|
| MULTIFIX™ S Ultra Knotless Fixation System: Internal Rotation Angle (12 months) |
75
(21.2)
|
| MULTIFIX™ S Ultra Knotless Fixation System: External Rotation (12 months) |
76
(21.9)
|
| FOOTPRINT™ Ultra PK Suture Anchor: Forward Flexion Angle (6 months) |
137.5
(35.9)
|
| FOOTPRINT™ Ultra PK Suture Anchor: Internal Rotation Angle (6 months) |
86.3
(30.9)
|
| FOOTPRINT™ Ultra PK Suture Anchor: External Rotation (6 months) |
50
(22.7)
|
| FOOTPRINT™ Ultra PK Suture Anchor: Forward Flexion Angle (12 months) |
140
(28.3)
|
| FOOTPRINT™ Ultra PK Suture Anchor: External Rotation (12 months) |
60
(0)
|
| SPEEDSCREW™ Knotless Fixation System: Forward Flexion Angle (6 months) |
122
(46.0)
|
| SPEEDSCREW™ Knotless Fixation System: External Rotation (6 months) |
35
(10)
|
| SPEEDSCREW™ Knotless Fixation System: Forward Flexion Angle (12 months) |
130
(NA)
|
| SPEEDSCREW™ Knotless Fixation System: External Rotation (12 months) |
50
(NA)
|
Adverse Events
| Time Frame | Surgery to End of Study (EOS) visit, approximately 12 months | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor). | |||||||||||||
| Arm/Group Title | HEALICOIL™ PK Preloaded Suture Anchors | BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors | MULTIFIX™ S Ultra Knotless Fixation System | FOOTPRINT™ Ultra PK Suture Anchors | TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and With Needles | SPEEDSCREW™ Knotless Fixation System | SpeedLock Knotless Fixation Device | |||||||
| Arm/Group Description | Participants who have received PEEK Suture Anchor: HEALICOIL™ PK Preloaded Suture Anchors | Participants who have received PEEK Suture Anchor: BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors | Participants who have received PEEK Suture Anchor: MULTIFIX™ S Ultra Knotless Fixation System | Participants who have received PEEK Suture Anchor: FOOTPRINT™ Ultra PK Suture Anchors | Participants who have received PEEK Suture Anchor: TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles | Participants who have received PEEK Suture Anchor: SPEEDSCREW™ Knotless Fixation System | Participants who have received PEEK Suture Anchor: SpeedLock Knotless Fixation Device | |||||||
All Cause Mortality |
||||||||||||||
| HEALICOIL™ PK Preloaded Suture Anchors | BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors | MULTIFIX™ S Ultra Knotless Fixation System | FOOTPRINT™ Ultra PK Suture Anchors | TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and With Needles | SPEEDSCREW™ Knotless Fixation System | SpeedLock Knotless Fixation Device | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/193 (0%) | 0/41 (0%) | 0/78 (0%) | 0/136 (0%) | 0/57 (0%) | 0/59 (0%) | 0/18 (0%) | |||||||
Serious Adverse Events |
||||||||||||||
| HEALICOIL™ PK Preloaded Suture Anchors | BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors | MULTIFIX™ S Ultra Knotless Fixation System | FOOTPRINT™ Ultra PK Suture Anchors | TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and With Needles | SPEEDSCREW™ Knotless Fixation System | SpeedLock Knotless Fixation Device | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 15/193 (7.8%) | 7/41 (17.1%) | 13/78 (16.7%) | 10/136 (7.4%) | 1/57 (1.8%) | 4/59 (6.8%) | 0/18 (0%) | |||||||
| Blood and lymphatic system disorders | ||||||||||||||
| PULMONARY EMBOLUS | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 1/59 (1.7%) | 1 | 0/18 (0%) | 0 |
| SPLENIC NECROSIS | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 1/59 (1.7%) | 1 | 0/18 (0%) | 0 |
| General disorders | ||||||||||||||
| LEFT SHOULDER PAIN WITH RECURRENT RTC TEAR | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT SHOULDER INCREASE IN PAIN WITH POPPING AND GRINDING, RECURRENT RTC TEAR | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| R SHOULDER INCREASED PAIN, WEAKNESS, LTD. ROM, R RECURRENT RTC TEAR | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER PAIN AND WEAKNESS RELATED TO RECURRENT RTC TEAR | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| FELT POP R SHOULDER, DECREASED ROM AND PAIN SINCE, RECURRENT RTC TEAR | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER SWELLING AND PAIN AFTER PT STRETCH AND RECURRENT LEFT RTC TEAR | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| R SHOULDER PAIN CREPITUS AND STIFFNESS WITH RECURRENT RTC TEAR, | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT SHOULDER PAIN AND WEAKNESS, RECURRENT R RTC TEAR, | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| INCREASED PAIN, DECREASED ROM AND WEAKNESS, RECURRENT L RTC TEAR, INSOMNIA R/T PAIN | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| WORSENING LEFT SHOULDER PAIN RADIATING DOWN LEFT ARM, RECURRENT LABRAL TEAR | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER PAIN WITH DECREASED ROM, STIFF AND SORE, ADHESIVE CAPSULITIS AND RTC TENDONITIS | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT SHOULDER PAIN, LTD ROM, RTC TEAR | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| R SHOULDER PAIN, RECURRENT RTC TEAR | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| Infections and infestations | ||||||||||||||
| R SHOULDER ANTERIOR WOUND INFECTION | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||
| RE-TEAR OF ROTATOR CUFF | 2/193 (1%) | 2 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 1/57 (1.8%) | 1 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER RECURRENT ROTATOR CUFF TEAR | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| R RECURRENT RTC TEAR AND IMPINGEMENT SYNDROME | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RECURRENT TEAR OF ROTATOR CUFF WITH NEW TEAR OF THE SUPRASPINATUS AND RECURRENT JOINT IMPINGEMENT | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT RTC TEAR, RTC CAPSULE SPRAIN | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| R SHOULDER TENDONITIS, PARTIAL RTC TEAR | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| R RTC TEAR, TENDONITIS AND WEAKNESS | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| CLAVICLE FRACTURE AFTER FALL AT WORK | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 1/59 (1.7%) | 1 | 0/18 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||
| ADHESIVE CAPSULITIS IN RIGHT SHOULDER | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER ADHESIVE CAPSULITIS | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 2/136 (1.5%) | 2 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| DECREASED ROM RIGHT SHOULDER | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| CONTINUING WEAKNESS RIGHT SHOULDER AND DECREASED ROM | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER PAIN AND DECREASED ROM | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RECURRENT RTC TEAR | 2/193 (1%) | 2 | 0/41 (0%) | 0 | 2/78 (2.6%) | 2 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT SHOULDER ADHESIVE CAPSULITIS | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| R SHOULDER SUBACHROMIAL BURSITIS WITH SUPRASPINATOUS TENDINOSIS CAUSING DECREASED MOBILITY | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT SHOULDER PAIN, TIGHTNESS AND SPASM WITH PERSISTENT WEAKNESS AND RECURRENT RTC TEAR | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| Nervous system disorders | ||||||||||||||
| RIGHT CARPAL TUNNEL WITH RELEASE | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||
| PNEMOTHORAX- RIGHT | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 1/59 (1.7%) | 1 | 0/18 (0%) | 0 |
| Surgical and medical procedures | ||||||||||||||
| OCCASIONAL LEFT SHOULDER PAIN, STIFFNESS, ADHESIVE CAPSULITIS | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||||
| HEALICOIL™ PK Preloaded Suture Anchors | BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors | MULTIFIX™ S Ultra Knotless Fixation System | FOOTPRINT™ Ultra PK Suture Anchors | TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and With Needles | SPEEDSCREW™ Knotless Fixation System | SpeedLock Knotless Fixation Device | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 40/193 (20.7%) | 27/41 (65.9%) | 38/78 (48.7%) | 24/136 (17.6%) | 5/57 (8.8%) | 4/59 (6.8%) | 0/18 (0%) | |||||||
| Blood and lymphatic system disorders | ||||||||||||||
| HYPERLIPIDEMIA | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 1/57 (1.8%) | 1 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| HYPERTENSION | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 1/57 (1.8%) | 1 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| Cardiac disorders | ||||||||||||||
| NEW ONSET ATRIAL FIBRILLATION | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| Endocrine disorders | ||||||||||||||
| RECURRENT 6MM RIGHT RTC TEAR SECONDARY TO DIABETES AND SMOKING CAUSING POOR TISSUE QUALITY | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||||
| NAUSEA AND CONSTIPATION R/T POST-OP OXYCONTIN | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| DIVERTICULITIS | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| ABDOMINAL PAIN AND CONSTIPATION | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| NAUSEA FROM PAIN MEDICATION | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| WORSENING LEFT SHOULDER PAIN AND DECREASED ROM | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| General disorders | ||||||||||||||
| COMPLEX REGIONAL PAIN SYNDROME TYPE II | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| PAIN ON THE RIGHT SIDE OF HER SHOULDER DOWN HER NECK AND THE MEDIAL BORDER OF HER RIGHT SCAPULA. | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 1/59 (1.7%) | 1 | 0/18 (0%) | 0 |
| RIGHT SIDE ARM PAIN | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 1/59 (1.7%) | 1 | 0/18 (0%) | 0 |
| SHOULDER PAIN POST FALL | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 1/59 (1.7%) | 1 | 0/18 (0%) | 0 |
| LEFT HAND NUMBNESS | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT SHOULDER PAIN | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| CONTINUED LEFT SHOULDER WEAKNESS | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| ACTIVE RANGE OF MOTION LIMITED BY PAIN | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| SHOOTING PAIN DOWN LEFT ARM | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT HAND CONTUSION | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| INCREASE IN RIGHT SHOULDER PAIN | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT ARM LIMITED ROM SECONDARY RIGHT SHOULDER PAIN FROM LIFTING INJURY | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| BILATERAL SHOULDER PAIN | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER INCREASING PAIN | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER CLICKING, NUMBNESS LEFT ARM, LEFT 4TH AND 5TH FINGERS | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| INSOMNIA R/T LEFT SHOULDER PAIN | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER PAIN WITH EXERCISING | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER STIFFNESS | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER SORENESS | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| NUMBNESS RIGHT THUMB | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| HERNIATED DISC WITH MYELOPATHY, CONTINUED RIGHT ARM WEAKNESS, RIGHT SCAPULA AREA AND SHOULDER PAIN | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| WORSENING RIGHT SHOULDER PAIN AND SWELLING | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT SHOULDER SORENESS AT TIMES | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| INSOMNIA SECONDARY TO RIGHT SHOULDER PAIN | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| POSTERIOR/LATERAL NUMBNESS RIGHT ARM | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT SHOULDER SWELLING | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| PAINFUL ROM | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| INCREASING RIGHT SHOULDER PAIN | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| CONTINUING SHOULDER PAIN | 1/193 (0.5%) | 1 | 2/41 (4.9%) | 2 | 3/78 (3.8%) | 3 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| PAIN DOWN ARM TO LEFT HAND 4TH AND 5TH FINGERS | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER BURSITIS | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER PAIN WITH DECREASED ROM | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER PAIN AFTER PT STRENGTHENING EXERCISES | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| TINGLING FROM LEFT ELBOW TO WRIST | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT ELBOW WARM TO TOUCH WITH DECREASED MOBILITY AND PAIN RADIATING TO WRIST | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| SHOULDER PAIN | 2/193 (1%) | 2 | 4/41 (9.8%) | 4 | 2/78 (2.6%) | 2 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT SHOULDER LIMITED ROM AND WEAKNESS | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| INCREASED PAIN RIGHT ANKLE | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| WORSENING PAIN RIGHT SHOULDER | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER PAIN, STIFFNESS, NUMBNESS AND DECREASED SENSATION RELATED TO RECURRENT RTC TEAR | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT SHOULDER ACHING PAIN WITH CERTAIN MOVEMENTS | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER MILD PAIN AND WEAKNESS | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| DECREASED LEFT SHOULDER STRENGTH | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER DECREASED ROM AND STRENGTH RELATED RTC RUPTURE | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER PAIN WITH DECREASED ROM | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER CONSTANT PAIN AND WEAKNESS RELATED TO RECURRENT RTC TEAR | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT ARM PAIN BICEP REGION AND LEFT SHOULDER SWELLING | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| OCCASIONAL SHOULDER PAIN | 2/193 (1%) | 2 | 3/41 (7.3%) | 3 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT SHOULDER PAIN AND WEAKNESS | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER DULL PAIN AFTER STRENUOUS ACTIVITY | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| INTERMITTENT LEFT SHOULDER PAIN SINCE EXERCISING | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| INTERMITTENT EPISODES OF PERSPIRING AND FEELING OF EXHAUSTION | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER DECREASED ROM | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER WEAKNESS AND PAIN | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| INTERMITTENT LEFT BICEP PAIN AND CRAMPING | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| INCREASED LUE PAIN WITH NUMBNESS AND TINGLING TO LEFT RADIAL DIGITS AND INSOMNIA RELATED TO PAIN | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| INCREASING LEFT SHOULDER PAIN | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| THUMB PAIN | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER PAIN AND RESIDUAL WEAKNESS | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER PAIN, LTD. ROM, WEAKNESS, DISUSE ATROPHY | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER STIFFNESS, CONSTANT SORENESS, DECREASED ROM, ACHING AND WEAKNESS | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT ANTERIOR SHIN NEURALGIA/SPRAIN | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| MIGRAINE HEADACHES | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| OCCASIONAL DEEP LEFT SHOULDER PAIN | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT ARM WEAKNESS | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| L SHOULDER PAIN W/LTD. ROM AND STRENGTH | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| INCREASED LEFT SHOULDER PAIN, HYPERSENSITIVITY AND PARASTHESIA, QUESTION POSSIBLE RSD | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| INTERMITTENT LEFT SHOULDER PAIN | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT SHOULDER PAIN WITH DECREASED ROM | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT SHOULDER PAIN WITH TIGHTNESS, WEAKNESS, AND DECREASED ROM | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| INTERMITTENT RIGHT SHOULDER PAIN | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER STIFFNESS AND LTD. ROM | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT SHOULDER SWELLING AND PAIN | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER STIFFNESS "SLEPT ON IT WRONG" | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| OCCASIONAL LEFT SHOULDER DECREASED ROM, PAIN, AND WEAKNESS | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RETURNING LEFT SHOULDER PAIN | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| R SHOULDER PAIN, DECREASED ROM AND BICEPS AREA PAIN | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER INTERMITTENT PAIN AND DECREASED ROM | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| CONTINUING RIGHT SHOULDER PAIN AND DECREASED ROM | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| REACHING IN PT AND FELT A "POP" WITH INCREASED PAIN RIGHT SHOULDER | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| WORSENING PAIN RIGHT SHOULDER | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER CONTINUING PAIN | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT SHOULDER PAIN AT NIGHT | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER POST. INCISION OPEN W/BLOOD DRAINAGE- SUTURE FELL OUT | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER WORSENING PAIN, LTD ROM | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RECURRING RIGHT ELBOW PAIN, ACUTE RIGHT EPICONDYLITIS | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| L SHOULDER PAIN, DECREASED ROM W/DIFFICULTY SLEEPING @ NIGHT, POSSIBLE ADHESIVE CAPSULITIS | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT ELBOW PAIN | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT FOREARM PAIN AND MUSCLE SPASMS | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT SHOULDER INSTABILITY AND PAIN R/T STRAIN/SPRAIN | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RECURRENT RIGHT SHOULDER PAIN, POST-OP REVISION | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| Infections and infestations | ||||||||||||||
| LEFT HAND THIRD FINGER PARONYCHIA VERY PAINFUL AND TENDER | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT SHOULDER SWELLING, REDNESS, WARMTH AND PAIN, CELLULITIS | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| CELLULITIS AND PURULENT DRAINAGE LEFT SHOULDER WOUND | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER ANTERIOR INCISIONS WITH MILD CELLULITIS | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| INFECTION/SMALL HEMATOMA | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||
| RIGHT SHOULDER DISCOMFORT SECONDARY TO FALL | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| FALL CAUSING RIGHT SHOULDER FORCED ABDUCTION | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| ROTATOR CUFF SPRAIN/STRAIN LEFT SHOULDER | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 2/136 (1.5%) | 2 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| ROTATOR CUFF SPRAIN/STRAIN RIGHT SHOULDER | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| INCREASED RIGHT SHOULDER PAIN R/T FALL | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT SHOULDER INCREASED PAIN AND STIFFNESS R/T CATCHING FALLING CLIENT | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT ANKLE SPRAIN WITH SWELLING AND PAIN R/T FALL | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT SHOULDER IMPINGEMENT SYNDROME, WITH LIMITED ADLS AND NIGHT PAIN | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT RTC SMALL PARTIAL THICKNESS TEAR | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER EDEMA | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RECURRENT RTC TEAR | 2/193 (1%) | 2 | 0/41 (0%) | 0 | 2/78 (2.6%) | 2 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| WORSENING LEFT SHOULDER PAIN AND SWELLING DUE TO FALLING IN SHOWER, CATCHING HERSELF WITH LEFT ARM | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT ROTATOR CUFF TENDONITIS, ACJ IMPINGEMENT | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| SLIPPED OFF CURB AND FELL ONTO LEFT ARM | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| PAIN FROM LEFT SHOULDER STRAIN | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT SHOULDER SURGICAL SCAR SENSITIVITY | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| REDNESS AND SWELLING AROUND INCISION FRONT OF RIGHT SHOULDER | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT BICIPITAL GROOVE TENDERNESS AFTER OVERSTRETCHING IN PT | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| CONTINUED POST-OP REVISION LEFT SHOULDER PAIN | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| POSSIBLE LEFT CUBITAL TUNNEL SYNDROME | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER PAIN POST MUA, LOA | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT ROTATOR CUFF RE-TEAR | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| ROTATOR CUFF RETEAR | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 1/57 (1.8%) | 1 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT ELBOW INJURY, POSSIBLE FRACTURE, OCCURRED DUE TO FALL | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 1/57 (1.8%) | 1 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| ROTATOR CUFF FAILURE / RECURRENT TEAR | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 1/59 (1.7%) | 1 | 0/18 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||
| LEFT SHOULDER TENDINITIS/BURSITIS | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| ADHESIVE CAPSULITIS | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| BICEPS ATROPHY | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| ADHESIVE CAPSULITIS RIGHT SHOULDER | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT BICEPS TENDONITIS | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT SHOULDER ADHESIVE CAPSULITIS POST RCR | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| PAINFUL HERNIATED CERVICAL DISC WITH MYELOPATHY | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| BICEPS TENDONITIS RIGHT SHOULDER | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT LATERAL EPICONDYLITIS | 2/193 (1%) | 2 | 0/41 (0%) | 0 | 2/78 (2.6%) | 2 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT TRICEPS TENDONITIS | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| NOCTURNAL AWAKENING DUE TO RIGHT SHOULDER TENDINOSIS | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| SMALL PARTIAL THICKNESS LEFT SUPRASPINATUS TEAR | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| DISCOMFORT RIGHT BICEP INTO NECK AND DISUSE ATROPHY | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER BURSITIS WITH DECREASED ROM AND WEAKNESS | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 1/78 (1.3%) | 1 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER MILD TENDINOSIS, POSSIBLE SLAP TEAR | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| PALPABLE TIGHTNESS RIGHT TRAPEZIUS AREA | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| GLENOHUMERAL INTERNAL ROTATION DEFICIT RIGHT SHOULDER | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT SHOULDER STIFFNESS | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT KNEE ARTHROFIBROSIS | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| LEFT ELBOW STIFFNESS | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RIGHT SHOULDER MUSCLE SPASMS | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| MASS OF SOFT TISSUE OF RIGHT UPPER EXTREMITY | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 1/57 (1.8%) | 1 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| Nervous system disorders | ||||||||||||||
| ULNAR NERVE SYMPTOMS AND MEDIAL SCAPULAR PAIN, NECK PAIN | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| HERNIATED DISC WITH MYELOPATHY | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| SEVERE CENTRAL SPINAL STENOSIS | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 1/57 (1.8%) | 1 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| Psychiatric disorders | ||||||||||||||
| NIGHTMARES FROM PERCOCET | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| GENERALIZED ANXIETY DISORDER | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 1/57 (1.8%) | 1 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| ADD | 1/193 (0.5%) | 1 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 1/57 (1.8%) | 1 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||||
| LEFT SHOULDER ANTERIOR PORTAL REDDENED AND SWOLLEN WITH RESOLVING BICEP ECCHYMOSIS | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| RAISED RASH RIGHT FOREARM AND RIGHT ARMPIT | 0/193 (0%) | 0 | 1/41 (2.4%) | 1 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| HERPES ZOSTER | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 0/136 (0%) | 0 | 1/57 (1.8%) | 1 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
| Vascular disorders | ||||||||||||||
| EXACERBATION HYPERTENSION | 0/193 (0%) | 0 | 0/41 (0%) | 0 | 0/78 (0%) | 0 | 1/136 (0.7%) | 1 | 0/57 (0%) | 0 | 0/59 (0%) | 0 | 0/18 (0%) | 0 |
Limitations/Caveats
No limitations reported
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Judith Horner |
|---|---|
| Organization | Smith+Nephew, Inc. |
| Phone | +44 1482 673251 |
| Judith.horner@smith-nephew.com |
Responsible Party:
Smith & Nephew, Inc.
ClinicalTrials.gov Identifier:
NCT03826667
Other Study ID Numbers:
- 2018.16.SMD.PEEK.RET.SHD
First Posted:
Feb 1, 2019
Last Update Posted:
Apr 12, 2022
Last Verified:
Feb 1, 2022