BioWick SureLock Clinical Outcomes Study

• ClinicalTrials.gov Identifier: NCT03199391
• Recruitment Status: Enrolling by invitation
• First Posted: June 26, 2017
• Last Update Posted: October 4, 2019
• Sponsor: Zimmer Biomet
• Information provided by (Responsible Party): Zimmer Biomet

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
Rotator Cuff Tear	Device: BioWick SureLock Implant

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, 12 months, and 24 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 24 months.

Primary Objective The primary objective of this study is to assess the structural failure rate 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 range of motion measurements, ASES scores, VR-12 scores, and VAS scores, with the corresponding assessments made at 3 months, 6 months, 12 months, and 24 months.
• To document device safety via device-related adverse events reported over the course of the study.

Study Design

• Study Type: Observational
• Estimated Enrollment: 83 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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: April 26, 2017
• Estimated Primary Completion Date: September 30, 2020
• Estimated Study Completion Date: May 31, 2023

Groups and Cohorts

Intervention Details:

• 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. Structural Failure Rate [ Time Frame: 6 months post-operative ]
   The primary endpoint of this study is the structural failure rate of the rotator cuff repair, determined by MRI, at 6 months following placement of the BioWick™ SureLock™ implant.

Secondary Outcome Measures :

1. Revision Rate [ Time Frame: 12 and 24 months post-operative ]
   Rate of the number of revisions of study devices
2. Structural Failure Rate [ Time Frame: 3 months post-operative ]
   Rate of failed structural integrity of rotator cuff
3. VR-12 Score [ Time Frame: 3, 6, 12, and 24 months post-operative ]
   brief, generic, multi-use, self-administered health surveys comprised of 36 and 12 items respectively. The instruments are primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific impact on general and selected populations.
4. ASES rating scale [ Time Frame: 3, 6, 12, and 24 months post-operative ]
   The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. The patient questions focus on joint pain, instability, and activities of daily living.
5. VAS Pain Scores [ Time Frame: 3, 6, 12, and 24 months post-operative ]
   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.
6. Range of Motion [ Time Frame: 3, 6, 12, and 24 months post-operative ]
   Range of motion: The full movement potential of a joint, usually its range of flexion and extension.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from patients requiring rotator cuff repair surgery.

Criteria

Inclusion Criteria:

• 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 with an intact subscapularis, confirmed 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.

Exclusion Criteria:

• Conditions which, in the opinion of the Principal Investigator, may limit the subject's ability or willingness to follow post-operative care or study instructions;
• If female, subject is pregnant;
• 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;
• Use of systemic corticosteroids at any daily dose for more

Contacts and Locations

Locations

United States, Arizona

The Orthopaedic Clinic Association

Phoenix, Arizona, United States, 85016

United States, California

Eisenhower Medical Center

Rancho Mirage, California, United States, 92270

United States, Florida

Orthopaedic Medical Group of Tampa Bay PA

Brandon, Florida, United States, 33511

Foundation for Orthopaedic Research and Eduation

Temple Terrace, Florida, United States, 33637

United States, Kentucky

Norton Orthopaedics and Sports Medicine

Louisville, Kentucky, United States, 40241

United States, Utah

University of Utah

Salt Lake City, Utah, United States, 84108

United States, Virginia

University of Virginia

Charlottesville, Virginia, United States, 22903

Sponsors and Collaborators

Zimmer Biomet

Investigators

• Study Director: Bill Bourdeau; bill.bourdeau@zimmerbiomet.com

More Information

• Responsible Party: Zimmer Biomet
• ClinicalTrials.gov Identifier: NCT03199391 History of Changes
• Other Study ID Numbers: CAY-001
• First Posted: June 26, 2017
• Last Update Posted: October 4, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: No
• Pediatric Postmarket Surveillance of a Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Rotator Cuff Injuries; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries