BioWick SureLock Clinical Outcomes Study

NCT03199391 | Completed Results FDA Device

• 1 other identifier: CAY-001
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 7

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.

Conditions

Rotator Cuff Tear

Outcome Measures

Primary Outcomes (1)

• Number of Participants Not Requiring Removal or Reoperation of the Implant

  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).

  12 months

Secondary Outcomes (7)

• Number of Participants Not Requiring Removal or Reoperation of the Implant

  3 months, 6 months

• American Shoulder and Elbow Surgeons (ASES) Patient Self-Evaluation Score

  Preoperative, 3 months, 6 months, 1 year

• Visual Analogue Scale (VAS) Pain Score

  Preoperative, 3 months, 6 months, 1 year

• The Veterans RAND 12 (VR-12) Item Health Survey Physical Score

  Preoperative, 3 months, 6 months, 1 year

• The Veterans RAND 12 (VR-12) Item Health Survey Mental Score

  Preoperative, 3 months, 6 months, 1 year

Study Arms (1)

BioWick SureLock Implant

EXPERIMENTAL

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

Device: BioWick SureLock Implant

Interventions

BioWick SureLock Implant 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.

BioWick SureLock Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Goutallier Stage 2 or less;
• Patte Stage II (mid humeral head retraction);
• Tear(s) confirmed intra-operatively by calibrated probe, tears measured in both anterior-posterior and medial-lateral planes;
• Subject is skeletally mature at the surgical site;
• Subject is able to read and understand the ICF and has voluntarily provided written informed consent.

You may not qualify if:

• Clinical diagnosis of a rotator cuff tear of the subscapularis that requires repair (not including debridement);
• Conditions which, in the opinion of the Principal Investigator, may limit the subject's ability or willingness to follow postoperative care or study instructions;
• If female, subject is pregnant;
• Presence of local or systemic infection;
• Suprascapular nerve compression requiring release or documented by EMG-NCV;
• Substance abuse, including tobacco, alcohol, or illicit drugs which, in the investigator's judgment, could impair healing or influence study compliance;
• Foreign body sensitivity. If material sensitivity is suspected, testing should be completed prior to device implantation;
• Insufficient blood supply or previous infection which may hinder the healing process;
• 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;
• Subject is a prisoner or member of another vulnerable population;
• Cortisone injection within 6 weeks prior to surgical treatment;
• Use of immune suppressants or chemotherapeutic medications within the last 12 months;
• Use of systemic corticosteroids at any daily dose for more than 1 month within the last 12 months.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (7)

The Orthopaedic Clinic Association

Phoenix, Arizona, 85016, United States

Location

Eisenhower Medical Center

Rancho Mirage, California, 92270, United States

Location

Orthopaedic Medical Group of Tampa Bay PA

Brandon, Florida, 33511, United States

Location

Foundation for Orthopaedic Research and Eduation

Temple Terrace, Florida, 33637, United States

Location

Norton Orthopaedics and Sports Medicine

Louisville, Kentucky, 40241, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Results Point of Contact

• Title: Madison Murphy
• Organization: Zimmer Biomet

madison.murphy@zimmerbiomet.com

5745262059

Study Officials

• Ryan Boylan

  ryan.boylan@zimmerbiomet.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: June 26, 2017
• Study Start: April 26, 2017
• Primary Completion: May 5, 2021
• Study Completion: May 5, 2021
• Last Updated: July 7, 2022
• Results First Posted: May 25, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)