BioWick SureLock Clinical Outcomes Study

• Sponsor: Zimmer Biomet (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03199391
• Collaborator: (none)
• Enrollment: 71
• Locations: 7
• Arm: 1
• Actual Duration (Months): 48.3
• Patients Per Site: 10.1
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to collect postmarket data in subjects who receive surgical treatment of a full-thickness rotator cuff tear (of at least 1.5 cm) with the BioWick™ SureLock™ implant. Both performance and safety data will be collected.

Condition or Disease	Intervention/Treatment	Phase
Rotator Cuff Tear	Device: BioWick SureLock Implant	N/A

Detailed Description

Study Title Efficacy of the BioWick SureLock Implant for the Reattachment of Soft Tissue to Bone in Subjects Undergoing Rotator Cuff Repairs

Sponsor Cayenne Medical, Inc., a Zimmer Biomet company

Study Design The study is a prospective, non-randomized, open-label, single-arm study that includes both preoperative assessments and follow-up assessments at 3 months, 6 months, and 12 months.

Clinical Phase Postmarket

Number of Sites Up to ten sites in the U.S.

Study Duration per Subject Subjects will be enrolled in the study for up to 12 months.

Primary Objective The primary objective of this study is to assess survivorship (lack of reoperation/device removal) with the use of the BioWick SureLock implant.

Secondary Objective

The secondary objectives of this study are:

• To document the postmarket effectiveness of the BioWick SureLock implant using ASES scores, VR-12 scores, and VAS scores, with the corresponding assessments made at 3 months, 6 months, and 12 months postoperative.

• To document the postmarket effectiveness of the BioWick SureLock implant using range of motion (ROM) measurements with the corresponding assessments made at 3 months and 6 months postoperative.

• To document device safety via device-related adverse events reported over the course of the study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 71 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of the BioWick SureLock Implant for the Reattachment of Soft Tissue to Bone in Subjects Undergoing Rotator Cuff Repairs
• Actual Study Start Date: Apr 26, 2017
• Actual Primary Completion Date: May 5, 2021
• Actual Study Completion Date: May 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BioWick SureLock Implant All subjects are part of a single arm. All subjects received the BioWick SureLock implant.	Device: BioWick SureLock Implant; The BioWick SureLock implant is a device for shoulder and extremity surgery, constructed of Ultra High Molecular Weight Polyethylene Suture. BioWick SureLock is uniquely designed to minimize these risks by avoiding manual tensioning with an inserter mechanism that ensures that the implant is consistently deployed below the cortex.

Outcome Measures

Primary Outcome Measures

1. Number of Participants Not Requiring Removal or Reoperation of the Implant [12 months]

   The primary endpoint of this study is survivorship (lack of reoperation/device removal) at 12 months postoperative. Implant survivorship for each subject was determined by whether the subject underwent a revision or reoperation of the study device. Survivorship was assessed using a Kaplan-Meier analysis. Possible scores range from 0% (lowest survivorship) to 100% (highest survivorship).

Secondary Outcome Measures

1. Number of Participants Not Requiring Removal or Reoperation of the Implant [3 months, 6 months]

   Implant survivorship (lack of reoperation/device removal) at 3 months and 6 months postoperative. Implant survivorship for each subject was determined by whether the subject underwent a revision or reoperation of the study device. Survivorship was assessed using a Kaplan-Meier analysis. Possible scores range from 0% (lowest survivorship) to 100% (highest survivorship).

2. American Shoulder and Elbow Surgeons (ASES) Patient Self-Evaluation Score [Preoperative, 3 months, 6 months, 1 year]

   Pain and function as measured by the American Society of Shoulder and Elbow Surgeons (ASES) questionnaire. ASES consists of 3 subcomponent scores including pain, instability, and activities of daily living. The pain score can be 0 to 10 with 0 being no pain and 10 being the worst pain imaginable. The instability score can be 0 to 10 with 0 being no instability and 10 being the worst instability imaginable. The activities of daily living consists of 10 questions with ordinal responses of 0, 1, 2, and 3 with 3 involving no limitation and 0 is unable to do. The 3 subcomponents combine to make the overall ASES score which can range from 0 to 100 with 0 being the worst possible score and 100 being the best.

3. Visual Analogue Scale (VAS) Pain Score [Preoperative, 3 months, 6 months, 1 year]

   A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. Possible scores range from 0 (no pain) to 10 (very much pain).

4. The Veterans RAND 12 (VR-12) Item Health Survey Physical Score [Preoperative, 3 months, 6 months, 1 year]

   A brief, generic, multi-use, self-administered health survey comprised of 12 items. The instruments are primarily used to measure health-related quality of life, to estimate disease burden, and to evaluate the disease-specific impact on general and selected populations. A higher VR-12 score indicates better health (0-100 scale).

5. The Veterans RAND 12 (VR-12) Item Health Survey Mental Score [Preoperative, 3 months, 6 months, 1 year]

   A brief, generic, multi-use, self-administered health survey comprised of 12 items. The instruments are primarily used to measure health-related quality of life, to estimate disease burden, and to evaluate the disease-specific impact on general and selected populations. A higher VR-12 score indicates better health (0-100 scale).

6. Range of Motion (ROM) - Active Forward Elevation [Preoperative, 3 months, 6 months, 1 year]

   Range of motion (ROM): The full movement potential of a joint, usually its range of flexion and extension. Normal range for active forward elevation is 150-180 degrees.

7. Device Safety [1 year]

   Safety evaluations were based on the frequency and incidence of device-related adverse events. Device-related adverse events included all reported adverse events classified as "Definitely" or "Possibly" related to the device. Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine collection occurred at each visit (3 months, 6 months, and 1 year). Additional details of reports of adverse events can be found in the Adverse Events section of the posted results.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Clinical diagnosis of rotator cuff tear which is greater than or equal to 1.5 cm and less than or equal to 4.0 cm full thickness of either the supraspinatus or infraspinatus determined by MRI which has not been previously repaired;

2. Goutallier Stage 2 or less;

3. Patte Stage II (mid humeral head retraction);

4. Tear(s) confirmed intra-operatively by calibrated probe, tears measured in both anterior-posterior and medial-lateral planes;

5. Subject is skeletally mature at the surgical site;

6. Subject is able to read and understand the ICF and has voluntarily provided written informed consent.

Exclusion Criteria:

1. Clinical diagnosis of a rotator cuff tear of the subscapularis that requires repair (not including debridement);

2. Conditions which, in the opinion of the Principal Investigator, may limit the subject's ability or willingness to follow postoperative care or study instructions;

3. If female, subject is pregnant;

4. Presence of local or systemic infection;

5. Suprascapular nerve compression requiring release or documented by EMG-NCV;

6. Substance abuse, including tobacco, alcohol, or illicit drugs which, in the investigator's judgment, could impair healing or influence study compliance;

7. Foreign body sensitivity. If material sensitivity is suspected, testing should be completed prior to device implantation;

8. Insufficient blood supply or previous infection which may hinder the healing process;

9. Subject conditions including: insufficient quantity or quality of bone or soft tissue, or immature bone where the device may impact or disrupt the growth plate;

10. Subject is a prisoner or member of another vulnerable population;

11. Cortisone injection within 6 weeks prior to surgical treatment;

12. Use of immune suppressants or chemotherapeutic medications within the last 12 months;

13. Use of systemic corticosteroids at any daily dose for more than 1 month within the last 12 months.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Orthopaedic Clinic Association	Phoenix	Arizona	United States	85016
2	Eisenhower Medical Center	Rancho Mirage	California	United States	92270
3	Orthopaedic Medical Group of Tampa Bay PA	Brandon	Florida	United States	33511
4	Foundation for Orthopaedic Research and Eduation	Temple Terrace	Florida	United States	33637
5	Norton Orthopaedics and Sports Medicine	Louisville	Kentucky	United States	40241
6	University of Utah	Salt Lake City	Utah	United States	84108
7	University of Virginia	Charlottesville	Virginia	United States	22903

Sponsors and Collaborators

• Zimmer Biomet

Investigators

• Study Director: Ryan Boylan, [e-mail]

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 22, 2020

More Information

Publications

None provided.

• Responsible Party: Zimmer Biomet
• ClinicalTrials.gov Identifier: NCT03199391
• Other Study ID Numbers: CAY-001
• First Posted: Jun 26, 2017
• Last Update Posted: Jul 7, 2022
• Last Verified: Jun 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: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Rotator Cuff Injuries

Study Results

Participant Flow

Pre-assignment Detail	Any screened subjects who met any of the exclusion criteria were excluded from participation in this study and were not considered enrolled subjects.

Arm/Group Title	BioWick SureLock Implant
Arm/Group Description	This arm included all subjects who were implanted with the BioWick SureLock Implant.
Period Title: Overall Study
STARTED	71
COMPLETED	55
NOT COMPLETED	16

Baseline Characteristics

Arm/Group Title	BioWick SureLock Implant
Arm/Group Description	This arm will include all subjects who are implanted with the BioWick SureLock Implant.
Overall Participants	71
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	60.5
Sex: Female, Male (Count of Participants)
Female	25 35.2%
Male	46 64.8%
Race/Ethnicity, Customized (Count of Participants)
African Origin	10 14.1%
Caucasian	56 78.9%
Hispanic	4 5.6%
Indian	1 1.4%
Region of Enrollment (Count of Participants)
United States	71 100%
Duration of Symptoms/Time Since Injury (months) [Mean (Full Range) ]
Mean (Full Range) [months]	14.9
Current tobacco use (Count of Participants)
No	63 88.7%
Yes	8 11.3%
Current alcohol use (Count of Participants)
No	33 46.5%
Yes	38 53.5%
Prior Shoulder Operations (Count of Participants)
No	49 69%
Yes	22 31%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Not Requiring Removal or Reoperation of the Implant
Description	The primary endpoint of this study is survivorship (lack of reoperation/device removal) at 12 months postoperative. Implant survivorship for each subject was determined by whether the subject underwent a revision or reoperation of the study device. Survivorship was assessed using a Kaplan-Meier analysis. Possible scores range from 0% (lowest survivorship) to 100% (highest survivorship).
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

In the statistical analysis of the primary effectiveness endpoint of the study, only subjects with evaluable endpoint were used in the statistical analysis, i.e., a complete case analysis.

Arm/Group Title	BioWick SureLock Implant
Arm/Group Description	This arm will include all subjects who are implanted with the BioWick SureLock Implant.
Measure Participants	71
Count of Participants [Participants]	69 97.2%

2. Secondary Outcome

Title	Number of Participants Not Requiring Removal or Reoperation of the Implant
Description	Implant survivorship (lack of reoperation/device removal) at 3 months and 6 months postoperative. Implant survivorship for each subject was determined by whether the subject underwent a revision or reoperation of the study device. Survivorship was assessed using a Kaplan-Meier analysis. Possible scores range from 0% (lowest survivorship) to 100% (highest survivorship).
Time Frame	3 months, 6 months

Outcome Measure Data

Analysis Population Description

In the statistical analysis of the primary effectiveness endpoint of the study, only subjects with evaluable endpoint were used in the statistical analysis, i.e., a complete case analysis.

Arm/Group Title	BioWick SureLock Implant
Arm/Group Description	This arm will include all subjects who are implanted with the BioWick SureLock Implant.
Measure Participants	71
3 months	69 97.2%
6 months	69 97.2%

3. Secondary Outcome

Title	American Shoulder and Elbow Surgeons (ASES) Patient Self-Evaluation Score
Description	Pain and function as measured by the American Society of Shoulder and Elbow Surgeons (ASES) questionnaire. ASES consists of 3 subcomponent scores including pain, instability, and activities of daily living. The pain score can be 0 to 10 with 0 being no pain and 10 being the worst pain imaginable. The instability score can be 0 to 10 with 0 being no instability and 10 being the worst instability imaginable. The activities of daily living consists of 10 questions with ordinal responses of 0, 1, 2, and 3 with 3 involving no limitation and 0 is unable to do. The 3 subcomponents combine to make the overall ASES score which can range from 0 to 100 with 0 being the worst possible score and 100 being the best.
Time Frame	Preoperative, 3 months, 6 months, 1 year

Outcome Measure Data

Analysis Population Description

The number analyzed at each interval represents the number of subjects who completed the respective follow-up visit, which may be less than the overall number of participants because of missed visits.

Arm/Group Title	BioWick SureLock Implant
Arm/Group Description	This arm will include all subjects who are implanted with the BioWick SureLock Implant.
Measure Participants	71
Preoperative	44.2 (17.1)
3 months	66.7 (19.9)
6 months	82.9 (15.8)
12 months	92.5 (10.2)

4. Secondary Outcome

Title	Visual Analogue Scale (VAS) Pain Score
Description	A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. Possible scores range from 0 (no pain) to 10 (very much pain).
Time Frame	Preoperative, 3 months, 6 months, 1 year

Outcome Measure Data

Analysis Population Description

The number analyzed at each interval represents the number of subjects who completed the respective follow-up visit, which may be less than the overall number of participants because of missed visits.

Arm/Group Title	BioWick SureLock Implant
Arm/Group Description	This arm will include all subjects who are implanted with the BioWick SureLock Implant.
Measure Participants	71
Preoperative	5.5 (2.4)
3 months	2.1 (2.4)
6 months	1.2 (1.6)
1 year	0.5 (0.9)

5. Secondary Outcome

Title	The Veterans RAND 12 (VR-12) Item Health Survey Physical Score
Description	A brief, generic, multi-use, self-administered health survey comprised of 12 items. The instruments are primarily used to measure health-related quality of life, to estimate disease burden, and to evaluate the disease-specific impact on general and selected populations. A higher VR-12 score indicates better health (0-100 scale).
Time Frame	Preoperative, 3 months, 6 months, 1 year

Outcome Measure Data

Analysis Population Description

The number analyzed at each interval represents the number of subjects who completed the respective follow-up visit, which may be less than the overall number of participants because of missed visits.

Arm/Group Title	BioWick SureLock Implant
Arm/Group Description	This arm will include all subjects who are implanted with the BioWick SureLock Implant.
Measure Participants	71
Preoperative	35.3 (8.3)
3 months	39.9 (8.4)
6 months	46.7 (8.7)
1 year	49.2 (7.3)

6. Secondary Outcome

Title	The Veterans RAND 12 (VR-12) Item Health Survey Mental Score
Description	A brief, generic, multi-use, self-administered health survey comprised of 12 items. The instruments are primarily used to measure health-related quality of life, to estimate disease burden, and to evaluate the disease-specific impact on general and selected populations. A higher VR-12 score indicates better health (0-100 scale).
Time Frame	Preoperative, 3 months, 6 months, 1 year

Outcome Measure Data

Analysis Population Description

The number analyzed at each interval represents the number of subjects who completed the respective follow-up visit, which may be less than the overall number of participants because of missed visits.

Arm/Group Title	BioWick SureLock Implant
Arm/Group Description	This arm will include all subjects who are implanted with the BioWick SureLock Implant.
Measure Participants	71
Preoperative	53.7 (11.3)
3 months	54.8 (11.2)
6 months	55.9 (9.1)
1 year	57.0 (6.5)

7. Secondary Outcome

Title	Range of Motion (ROM) - Active Forward Elevation
Description	Range of motion (ROM): The full movement potential of a joint, usually its range of flexion and extension. Normal range for active forward elevation is 150-180 degrees.
Time Frame	Preoperative, 3 months, 6 months, 1 year

Outcome Measure Data

Analysis Population Description

The number analyzed at each interval represents the number of subjects who completed the respective follow-up visit, which may be less than the overall number of participants because of missed visits.

Arm/Group Title	BioWick SureLock Implant
Arm/Group Description	This arm will include all subjects who are implanted with the BioWick SureLock Implant.
Measure Participants	71
Preoperative	116.1 (42.1)
3 months	132.1 (30.8)
6 months	153.4 (23.3)
1 year	162.1 (18.7)

8. Secondary Outcome

Title	Device Safety
Description	Safety evaluations were based on the frequency and incidence of device-related adverse events. Device-related adverse events included all reported adverse events classified as "Definitely" or "Possibly" related to the device. Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine collection occurred at each visit (3 months, 6 months, and 1 year). Additional details of reports of adverse events can be found in the Adverse Events section of the posted results.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

All enrolled subjects were analyzed for device safety through the end of their study participation.

Arm/Group Title	BioWick SureLock Implant
Arm/Group Description	This arm will include all subjects who are implanted with the BioWick SureLock Implant.
Measure Participants	71
Number [device-related adverse events]	8

Adverse Events

Time Frame	3 months, 6 months, and 1 year
Adverse Event Reporting Description	Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
Arm/Group Title	BioWick SureLock Implant
Arm/Group Description	This arm will include all subjects who are implanted with the BioWick SureLock Implant.
All Cause Mortality
	BioWick SureLock Implant
	Affected / at Risk (%)	# Events
Total	1/71 (1.4%)
Serious Adverse Events
	BioWick SureLock Implant
	Affected / at Risk (%)	# Events
Total	5/71 (7%)
Cardiac disorders
Chest pain and received heart catheter	1/71 (1.4%)
Chest pain	1/71 (1.4%)
Gastrointestinal disorders
Bowel obstruction	1/71 (1.4%)
Infections and infestations
Stepped on a nail with right foot.	1/71 (1.4%)
Musculoskeletal and connective tissue disorders
Increased pain, loose rotator cuff anchor (non-study device)	1/71 (1.4%)
Left knee OA	1/71 (1.4%)
Respiratory, thoracic and mediastinal disorders
Subject death after no longer able to breathe	1/71 (1.4%)
Other (Not Including Serious) Adverse Events
	BioWick SureLock Implant
	Affected / at Risk (%)	# Events
Total	29/71 (40.8%)
General disorders
Headaches for 2 weeks	1/71 (1.4%)
Metal shaving in left 3rd toe	1/71 (1.4%)
Musculoskeletal and connective tissue disorders
Tear and retraction of entire supraspinatus tendon	1/71 (1.4%)
Adhesive capsulitis	1/71 (1.4%)
3 month MRI shows recurrent full-thickness tear of the supraspinatus	1/71 (1.4%)
Right rotator cuff tear	1/71 (1.4%)
Worsening of left shoulder pain	1/71 (1.4%)
Patient is stiff at 3 month and 6 month visit	1/71 (1.4%)
Tightness in trigger points within the cervical paraspinous muscles and levator scapular muscle	1/71 (1.4%)
Right (contralateral) shoulder pain after fall	1/71 (1.4%)
Full thickness defect of the anterior supraspinatus tendon just medial to the biowick anchors	1/71 (1.4%)
Left shoulder pain with certain movements	1/71 (1.4%)
Patient presented with ipsilateral bursitis/adhesive capsulitis	1/71 (1.4%)
Patient healed quickly and subsequently developed capsulitis	1/71 (1.4%)
Right shoulder pain	1/71 (1.4%)
Medial meniscus tear on right knee	1/71 (1.4%)
Patient fell off bike and ruptured his achilles tendon	1/71 (1.4%)
Increased pain in right shoulder and neck radiating to fingers	1/71 (1.4%)
At 3 month visit, patient is noted to be stiff	1/71 (1.4%)
Patient developed lateral epicondylitis of right humerus	1/71 (1.4%)
6 month MRI report notes a re-tear of the supraspinatus and associated bursal-sided fluid build-up	1/71 (1.4%)
Adhesive capsulitis/arthro fibrosis diagnosed.	1/71 (1.4%)
Loosened posterior superior anchor with fluid collection and retraction.	1/71 (1.4%)
Capsulitis/stiffness. Required cortisone injection	1/71 (1.4%)
3/4 weeks post-op, patient developed erythema. Required surgical debridement and ROH.	1/71 (1.4%)
Patient presented to the pain clinic with known history of migraine headaches	1/71 (1.4%)
New full-thickness tear at the supraspinatus/infraspinatus junction from shoveling.	1/71 (1.4%)
3 month MRI reports recurrent tear which becomes symptomatic sometimes	1/71 (1.4%)
R shoulder pain/difficulty with throwing activities and shoulder movement	1/71 (1.4%)
New tenderness of left shoulder	1/71 (1.4%)
Nervous system disorders
Neck pain - post op cervical discectomy	1/71 (1.4%)
Sharp stabbing pain down middle of back. Preexisting back pain got much worse right after surgery	1/71 (1.4%)
Worsening of lumbar degenerative disc disease	1/71 (1.4%)
Low back pain with radiation into left thigh	1/71 (1.4%)
Neck pain and decreased ROM related to degenerative cervical disc disease	1/71 (1.4%)
Renal and urinary disorders
Urinary retention	1/71 (1.4%)
Respiratory, thoracic and mediastinal disorders
Presented to the ed with complaints of cough and wheezing x 2 weeks	1/71 (1.4%)
COPD	1/71 (1.4%)
Skin and subcutaneous tissue disorders
Melanoma excision on right shoulder	1/71 (1.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT 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.