Comparison of ARPE Prosthesis With the Literature
Study Details
Study Description
Brief Summary
This study is designed to document the objective and subjective measurements after trapeziometacarpal athroplasty with ARPE prosthesis and to compare those to literature values of outcome after trapeziectomy and trapeziectomy with ligament reconstruction and tendon interposition (LRTI), as published in a recent meta-analysis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
The primary objective is to compare functional outcome at 3 years after trapezio-metarcarpal arthroplasty with trapeziectomy and trapeziectomy with ligament reconstruction and tendon interposition. Literature values obtained by a recently published meta analysis will be used.
The secondary objectives are:
-
to compare functional outcome at 1 and at 5 years after trapezio-metarcarpal arthroplasty with trapeziectomy and trapeziectomy with ligament reconstruction and tendon interposition
-
to determine pre- and post-operative HR QOL
-
Incidence of radiolucencies at each follow up time point. Literature values from the same meta analysis will be used,
Patients will be assessed at preoperatively, and at 1, 3 and 5 years postoperatively. Measured Outcomes: grip strength, tip pinch strength, key pinch strength, pain, occurrence of adverse events, hand function.
Study Design
Outcome Measures
Primary Outcome Measures
- Grip Strength [Pre-operative, 1, 3 and 5 years follow-up]
Grip strength is an indicator of muscle health in the hands and forearms and is measured with a hand-held dynamometer. The patients squeeze the dynamometer with all of their strength and the force applied is measured.
- Key Pinch Strength [Pre-operative, 1, 3 and 5 years follow-up]
Key pinch strength is an indicator of muscle health and measures the precision grip by using a pinch dynamometer. The device is placed between the radial side of the index finger and thumb and the force applied while the patients pinch as hard as possible is measured.
- Tip Pinch Strength [Pre-operative, 1, 3 and 5 years follow-up]
Tip pinch strength is an indicator of muscle health and measures the precision grip by using a pinch dynamometer. The device is placed between the tip of the index finger and thumb and the force applied while the patients pinch as hard as possible is measured.
- VAS Pain [Pre-operative, 1, 3 and 5 years follow-up]
Pain level is collected with VAS (Visual Analog Scale): the patients are asked to mark their current pain level on a horizontal line containing values ranging from 0 (no pain) to 100 (very severe pain).
Secondary Outcome Measures
- Motion - ROM Measurement - Radial Abduction [Pre-operative, 1, 3 and 5 years follow-up]
The range of motion (ROM) is the extent of movement of a joint and indicates the range through which the joint can be moved. ROM in radial abduction is measured while the patients move the thumb in parallel to the palm.
- Motion - ROM Measurement - Palmar Abduction [Pre-operative, 1, 3 and 5 years follow-up]
The range of motion (ROM) is the extent of movement of a joint and indicates the range through which the joint can be moved. The ROM in palmar abduction is measured while the patients move the thumb perpendicularly to the palm.
- EQ-5D - Health Status Score [Pre-operative, 1, 3 and 5 years follow-up]
EQ-5D is a standardized instrument for measuring the health-related quality of life, which assesses health status in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each question has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to), which are singularly rated and then combined into a health status score. The health status score ranges from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.
- EQ-5D - VAS Score [Pre-operative, 1, 3 and 5 years follow-up]
The second part of the EQ-5D questionnaire consists of a visual analogue scale (VAS) on which the patient rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).
- Number of Implants With Visible Radiolucency Line Around the Implanted Prosthesis [1, 3 and 5 years follow-up]
Radiolucency lines are radiolucent gaps visible in the radiographic images between the prosthesis and the bone, which presence is commonly associated with early failure of the implantation, eventually leading to the loosening of the prosthesis. Every radiography taken at each follow-up time point was assessed to evaluate whether there are visible radiolucency lines around the implanted prosthesis and the number of implants with visible radiolucency lines is here reported.
- Hand Function: DASH Questionnaire - Disability [Pre-operative, 1, 3 and 5 years follow-up]
The DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire outcome measure is a 30-item, self-report questionnaire designed to assess the patients' health status during the previous week by asking to rate their ability to perform various daily activities. The questions are grouped in 3 categories: disability, work and sport, of which work and sport are optional. The score ranges from 0 (no disability) to 100 (most severe disability), with higher scores indicating a greater level of disability and severity, whereas lower scores indicate a lower level of disability.
- Hand Function: DASH Questionnaire - Work [Pre-operative, 1, 3 and 5 years follow-up]
The DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire outcome measure is a 30-item, self-report questionnaire designed to assess the patients' health status during the previous week by asking to rate their ability to perform various daily activities. The questions are grouped in 3 categories: disability, work and sport, of which work and sport are optional. The score ranges from 0 (no disability) to 100 (most severe disability), with higher scores indicating a greater level of disability and severity, whereas lower scores indicate a lower level of disability.
- Hand Function: DASH Questionnaire - Sport [Pre-operative, 1, 3 and 5 years follow-up]
The DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire outcome measure is a 30-item, self-report questionnaire designed to assess the patients' health status during the previous week by asking to rate their ability to perform various daily activities. The questions are grouped in 3 categories: disability, work and sport, of which work and sport are optional. The score ranges from 0 (no disability) to 100 (most severe disability), with higher scores indicating a greater level of disability and severity, whereas lower scores indicate a lower level of disability.
Eligibility Criteria
Criteria
Inclusion/exclusion criteria are identical to those indications and contraindications stated in the package insert of the implant.
Inclusion Criteria:
-
patients with trapezio-metacarpal arthritis Eaton Stage of trapezio-metacarpal arthritis: Stage II - IV
-
patients willing to return for follow up evaluation.
Exclusion Criteria:
-
local or systemic infections
-
severe muscular, neurological or vascular deficiencies of the extremity involved
-
bone destruction or poor bone to affect implant stability
-
allergy to any of the components of the implant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | SPM Deurne | Deurne | Belgium | 2100 |
Sponsors and Collaborators
- Zimmer Biomet
- Biomet Belgium BVBA
Investigators
- Principal Investigator: Frederik VERSTREKEN, PhD, SPM Deurne
Study Documents (Full-Text)
More Information
Publications
None provided.- ORTHO.CR.E16
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | According to the protocol, 100 subjects were to be enrolled. Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. |
| Arm/Group Title | ARPE Prosthesis |
|---|---|
| Arm/Group Description | Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis. |
| Period Title: Pre-operative | |
| STARTED | 95 |
| COMPLETED | 95 |
| NOT COMPLETED | 0 |
| Period Title: Pre-operative | |
| STARTED | 95 |
| COMPLETED | 86 |
| NOT COMPLETED | 9 |
| Period Title: Pre-operative | |
| STARTED | 86 |
| COMPLETED | 71 |
| NOT COMPLETED | 15 |
| Period Title: Pre-operative | |
| STARTED | 71 |
| COMPLETED | 65 |
| NOT COMPLETED | 6 |
Baseline Characteristics
| Arm/Group Title | ARPE Prosthesis |
|---|---|
| Arm/Group Description | Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis. |
| Overall Participants | 95 |
| Overall implants | 100 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
62.3
(7.2)
|
| Sex: Female, Male (implants) [Count of Units] | |
| Female |
87
|
| Male |
13
|
| Race and Ethnicity Not Collected (Count of Participants) | |
| Surgery Side Distribution (implants) [Count of Units] | |
| Left |
59
|
| Right |
41
|
| Weight Distribution (kg) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [kg] |
70.4
(14.5)
|
| Height Distribution (cm) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [cm] |
165.3
(7.4)
|
| Other Joint Involvement of the Hand (implants) [Count of Units] | |
| No |
31
|
| Yes |
69
|
| Previous Hand Surgeries/Treatments on Affected Hand (implants) [Count of Units] | |
| No |
77
|
| Yes |
23
|
| Trapezio Metacarpal Arthritis Disease Stage (implants) [Count of Units] | |
| Stage II |
26
|
| Stage III |
68
|
| Stage IV |
6
|
Outcome Measures
| Title | Grip Strength |
|---|---|
| Description | Grip strength is an indicator of muscle health in the hands and forearms and is measured with a hand-held dynamometer. The patients squeeze the dynamometer with all of their strength and the force applied is measured. |
| Time Frame | Pre-operative, 1, 3 and 5 years follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number. |
| Arm/Group Title | ARPE Prosthesis |
|---|---|
| Arm/Group Description | Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis. |
| Measure Participants | 95 |
| Measure implants | 100 |
| Pre-operative |
17.8
(8.7)
|
| 1 year follow-up |
23.4
(9.2)
|
| 3 years follow-up |
24.7
(10.3)
|
| 5 years follow-up |
25
(8.9)
|
| Title | Key Pinch Strength |
|---|---|
| Description | Key pinch strength is an indicator of muscle health and measures the precision grip by using a pinch dynamometer. The device is placed between the radial side of the index finger and thumb and the force applied while the patients pinch as hard as possible is measured. |
| Time Frame | Pre-operative, 1, 3 and 5 years follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number. |
| Arm/Group Title | ARPE Prosthesis |
|---|---|
| Arm/Group Description | Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis. |
| Measure Participants | 95 |
| Measure implants | 100 |
| Pre-operative |
3.6
(2.1)
|
| 1 year follow-up |
5.8
(2.3)
|
| 3 years follow-up |
5.5
(2.1)
|
| 5 years follow-up |
5.9
(2.0)
|
| Title | Tip Pinch Strength |
|---|---|
| Description | Tip pinch strength is an indicator of muscle health and measures the precision grip by using a pinch dynamometer. The device is placed between the tip of the index finger and thumb and the force applied while the patients pinch as hard as possible is measured. |
| Time Frame | Pre-operative, 1, 3 and 5 years follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number. |
| Arm/Group Title | ARPE Prosthesis |
|---|---|
| Arm/Group Description | Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis. |
| Measure Participants | 95 |
| Measure implants | 100 |
| Pre-operative |
2.7
(1.6)
|
| 1 year follow-up |
4.5
(1.8)
|
| 3 years follow-up |
4.6
(2)
|
| 5 years follow-up |
4.5
(1.5)
|
| Title | VAS Pain |
|---|---|
| Description | Pain level is collected with VAS (Visual Analog Scale): the patients are asked to mark their current pain level on a horizontal line containing values ranging from 0 (no pain) to 100 (very severe pain). |
| Time Frame | Pre-operative, 1, 3 and 5 years follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number. |
| Arm/Group Title | ARPE Prosthesis |
|---|---|
| Arm/Group Description | Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis. |
| Measure Participants | 95 |
| Measure implants | 100 |
| Pre-operative |
59.3
(19.5)
|
| 1 year follow-up |
11.1
(14.8)
|
| 3 years follow-up |
10.3
(19.6)
|
| 5 years follow-up |
7.1
(15.1)
|
| Title | Motion - ROM Measurement - Radial Abduction |
|---|---|
| Description | The range of motion (ROM) is the extent of movement of a joint and indicates the range through which the joint can be moved. ROM in radial abduction is measured while the patients move the thumb in parallel to the palm. |
| Time Frame | Pre-operative, 1, 3 and 5 years follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number. |
| Arm/Group Title | ARPE Prosthesis |
|---|---|
| Arm/Group Description | Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis. |
| Measure Participants | 95 |
| Measure implants | 100 |
| Pre-operative |
41.5
(7.1)
|
| 1 year follow-up |
53.1
(37.8)
|
| 3 years follow-up |
47.5
(6.1)
|
| 5 years follow-up |
43.8
(9.9)
|
| Title | Motion - ROM Measurement - Palmar Abduction |
|---|---|
| Description | The range of motion (ROM) is the extent of movement of a joint and indicates the range through which the joint can be moved. The ROM in palmar abduction is measured while the patients move the thumb perpendicularly to the palm. |
| Time Frame | Pre-operative, 1, 3 and 5 years follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number. |
| Arm/Group Title | ARPE Prosthesis |
|---|---|
| Arm/Group Description | Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis. |
| Measure Participants | 95 |
| Measure implants | 100 |
| Pre-operative |
43.2
(5.8)
|
| 1 year follow-up |
48.1
(6.4)
|
| 3 years follow-up |
47.8
(5.9)
|
| 5 years follow-up |
43.4
(8.4)
|
| Title | EQ-5D - Health Status Score |
|---|---|
| Description | EQ-5D is a standardized instrument for measuring the health-related quality of life, which assesses health status in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each question has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to), which are singularly rated and then combined into a health status score. The health status score ranges from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. |
| Time Frame | Pre-operative, 1, 3 and 5 years follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number. |
| Arm/Group Title | ARPE Prosthesis |
|---|---|
| Arm/Group Description | Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis. |
| Measure Participants | 95 |
| Measure implants | 100 |
| Pre-operative |
0.4
(0.3)
|
| 1 year follow-up |
0.8
(0.3)
|
| 3 year follow-up |
0.8
(0.3)
|
| 5 year follow-up |
0.8
(0.3)
|
| Title | EQ-5D - VAS Score |
|---|---|
| Description | The second part of the EQ-5D questionnaire consists of a visual analogue scale (VAS) on which the patient rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health). |
| Time Frame | Pre-operative, 1, 3 and 5 years follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number. |
| Arm/Group Title | ARPE Prosthesis |
|---|---|
| Arm/Group Description | Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis. |
| Measure Participants | 95 |
| Measure implants | 100 |
| Pre-operative |
72.7
(15.8)
|
| 1 year follow-up |
74.1
(19.5)
|
| 3 years follow-up |
77.9
(15.7)
|
| 5 years follow-up |
76.2
(17.2)
|
| Title | Number of Implants With Visible Radiolucency Line Around the Implanted Prosthesis |
|---|---|
| Description | Radiolucency lines are radiolucent gaps visible in the radiographic images between the prosthesis and the bone, which presence is commonly associated with early failure of the implantation, eventually leading to the loosening of the prosthesis. Every radiography taken at each follow-up time point was assessed to evaluate whether there are visible radiolucency lines around the implanted prosthesis and the number of implants with visible radiolucency lines is here reported. |
| Time Frame | 1, 3 and 5 years follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number. There were no radiolucency lines reported for any of the patients included in the study at any time point. |
| Arm/Group Title | ARPE Prosthesis |
|---|---|
| Arm/Group Description | Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis. |
| Measure Participants | 95 |
| Measure implants | 100 |
| 1 years follow-up |
0
|
| 3 years follow-up |
0
|
| 5 years follow-up |
0
|
| Title | Hand Function: DASH Questionnaire - Disability |
|---|---|
| Description | The DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire outcome measure is a 30-item, self-report questionnaire designed to assess the patients' health status during the previous week by asking to rate their ability to perform various daily activities. The questions are grouped in 3 categories: disability, work and sport, of which work and sport are optional. The score ranges from 0 (no disability) to 100 (most severe disability), with higher scores indicating a greater level of disability and severity, whereas lower scores indicate a lower level of disability. |
| Time Frame | Pre-operative, 1, 3 and 5 years follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number. |
| Arm/Group Title | ARPE Prosthesis |
|---|---|
| Arm/Group Description | Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis. |
| Measure Participants | 95 |
| Measure implants | 100 |
| Pre-operative |
41.7
(17.9)
|
| 1 year follow-up |
10.6
(14.3)
|
| 3 year follow-up |
10.2
(14.2)
|
| 5 year follow-up |
8.5
(11.8)
|
| Title | Hand Function: DASH Questionnaire - Work |
|---|---|
| Description | The DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire outcome measure is a 30-item, self-report questionnaire designed to assess the patients' health status during the previous week by asking to rate their ability to perform various daily activities. The questions are grouped in 3 categories: disability, work and sport, of which work and sport are optional. The score ranges from 0 (no disability) to 100 (most severe disability), with higher scores indicating a greater level of disability and severity, whereas lower scores indicate a lower level of disability. |
| Time Frame | Pre-operative, 1, 3 and 5 years follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number. The Work category is optional. |
| Arm/Group Title | ARPE Prosthesis |
|---|---|
| Arm/Group Description | Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis. |
| Measure Participants | 95 |
| Measure implants | 100 |
| Pre-operative |
46.1
(25.9)
|
| 1 year follow-up |
11.1
(17.2)
|
| 3 year follow-up |
7.8
(16.5)
|
| 5 year follow-up |
5.8
(13.5)
|
| Title | Hand Function: DASH Questionnaire - Sport |
|---|---|
| Description | The DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire outcome measure is a 30-item, self-report questionnaire designed to assess the patients' health status during the previous week by asking to rate their ability to perform various daily activities. The questions are grouped in 3 categories: disability, work and sport, of which work and sport are optional. The score ranges from 0 (no disability) to 100 (most severe disability), with higher scores indicating a greater level of disability and severity, whereas lower scores indicate a lower level of disability. |
| Time Frame | Pre-operative, 1, 3 and 5 years follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number. The Sports category is optional. |
| Arm/Group Title | ARPE Prosthesis |
|---|---|
| Arm/Group Description | Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis. |
| Measure Participants | 95 |
| Measure implants | 100 |
| Pre-operative |
48.7
(32.4)
|
| 1 year follow-up |
6.7
(13.4)
|
| 3 year follow-up |
10.1
(21.8)
|
| 5 year follow-up |
2.2
(5.8)
|
Adverse Events
| Time Frame | Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. | |
|---|---|---|
| Adverse Event Reporting Description | Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome. | |
| Arm/Group Title | ARPE Prosthesis | |
| Arm/Group Description | Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis. | |
All Cause Mortality |
||
| ARPE Prosthesis | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/95 (0%) | |
Serious Adverse Events |
||
| ARPE Prosthesis | ||
| Affected / at Risk (%) | # Events | |
| Total | 17/95 (17.9%) | |
| Cardiac disorders | ||
| Heart arrhythmia | 1/95 (1.1%) | 1 |
| Gastrointestinal disorders | ||
| Gastric bleeding | 1/95 (1.1%) | 1 |
| General disorders | ||
| Anaphylactic shock | 1/95 (1.1%) | 1 |
| Malnutrition | 1/95 (1.1%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Prosthesis luxation | 5/95 (5.3%) | 6 |
| Neck problems | 1/95 (1.1%) | 1 |
| Rizarthrosis | 1/95 (1.1%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Prostate cancer | 1/95 (1.1%) | 1 |
| Colon cancer | 1/95 (1.1%) | 1 |
| Renal and urinary disorders | ||
| Bladder prolapse | 1/95 (1.1%) | 1 |
| Reproductive system and breast disorders | ||
| Prostate hypertrophy | 1/95 (1.1%) | 1 |
| Surgical and medical procedures | ||
| Hip replacement | 2/95 (2.1%) | 2 |
| Discectomy | 1/95 (1.1%) | 1 |
| Gonarthrosis | 1/95 (1.1%) | 1 |
| Cuff tear shoulder | 1/95 (1.1%) | 1 |
| Fracture of pseudoarthrosis radius | 1/95 (1.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| ARPE Prosthesis | ||
| Affected / at Risk (%) | # Events | |
| Total | 19/95 (20%) | |
| Infections and infestations | ||
| Thumb infection | 1/95 (1.1%) | 2 |
| Musculoskeletal and connective tissue disorders | ||
| Thumb pain | 3/95 (3.2%) | 3 |
| Tenosynovitis | 11/95 (11.6%) | 13 |
| Thumb and/or wrist pain | 1/95 (1.1%) | 1 |
| Carpal tunnel | 4/95 (4.2%) | 5 |
| Arthrosis | 1/95 (1.1%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Emilie Rohmer, Clinical Operations Manager |
|---|---|
| Organization | Zimmer Biomet |
| Phone | +41 58 85 48210 |
| Emilie.Rohmer@zimmerbiomet.com |
- ORTHO.CR.E16