N/A N=71 Treatment

BioWick SureLock Clinical Outcomes Study

Rotator Cuff Tear

Bottom Line

View on ClinicalTrials.gov: NCT03199391 ↗

Enrolled (actual)

Serious AEs

7.0%

Results posted

May 2022

Primary outcome: Primary: Number of Participants Not Requiring Removal or Reoperation of the Implant — 69 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: BioWick SureLock Implant (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Zimmer Biomet
Primary completion: May 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Not Requiring Removal or Reoperation of the Implant	69; 69	—
SECONDARY Number of Participants Not Requiring Removal or Reoperation of the Implant	69; 69	—
SECONDARY American Shoulder and Elbow Surgeons (ASES) Patient Self-Evaluation Score	44.2; 66.7; 82.9; 92.5	—
SECONDARY Visual Analogue Scale (VAS) Pain Score	5.5; 2.1; 1.2; 0.5	—
SECONDARY The Veterans RAND 12 (VR-12) Item Health Survey Physical Score	35.3; 39.9; 46.7; 49.2	—
SECONDARY The Veterans RAND 12 (VR-12) Item Health Survey Mental Score	53.7; 54.8; 55.9; 57.0	—
SECONDARY Range of Motion (ROM) - Active Forward Elevation	116.1; 132.1; 153.4; 162.1	—
SECONDARY Device Safety	8	—

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.

Eligibility 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 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.

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03199391). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.