BioWick SureLock Clinical Outcomes Study

NCT ID: NCT03199391

Last Updated: 2022-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-26
• Study Completion Date: 2021-05-05

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.

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.

Conditions

Rotator Cuff Tear

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BioWick SureLock Implant

All subjects are part of a single arm. All subjects received the BioWick SureLock implant.

Group Type: EXPERIMENTAL

BioWick SureLock Implant

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan Boylan

Role: STUDY_DIRECTOR

ryan.boylan@zimmerbiomet.com

Locations

The Orthopaedic Clinic Association

Phoenix, Arizona, United States

Eisenhower Medical Center

Rancho Mirage, California, United States

Orthopaedic Medical Group of Tampa Bay PA

Brandon, Florida, United States

Foundation for Orthopaedic Research and Eduation

Temple Terrace, Florida, United States

Norton Orthopaedics and Sports Medicine

Louisville, Kentucky, United States

University of Utah

Salt Lake City, Utah, United States

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CAY-001

Identifier Type: -

Identifier Source: org_study_id