Clinical trial NCT03199391: BioWick SureLock Clinical Outcomes Study
Official title: Efficacy of the BioWick SureLock Implant for the Reattachment of Soft Tissue to Bone in Subjects Undergoing Rotator Cuff Repairs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tear
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2017-06-26
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants Not Requiring Removal or Reoperation of the Implant
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants Not Requiring Removal or Reoperation of the Implant
timeFrame: 3 months, 6 months
measure: American Shoulder and Elbow Surgeons (ASES) Patient Self-Evaluation Score
timeFrame: Preoperative, 3 months, 6 months, 1 year
measure: Visual Analogue Scale (VAS) Pain Score
timeFrame: Preoperative, 3 months, 6 months, 1 year
measure: The Veterans RAND 12 (VR-12) Item Health Survey Physical Score
timeFrame: Preoperative, 3 months, 6 months, 1 year
measure: The Veterans RAND 12 (VR-12) Item Health Survey Mental Score
timeFrame: Preoperative, 3 months, 6 months, 1 year
measure: Range of Motion (ROM) - Active Forward Elevation
timeFrame: Preoperative, 3 months, 6 months, 1 year
measure: Device Safety
timeFrame: 1 year
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: The Orthopaedic Clinic Association
state: Arizona
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center
state: California
city: Brandon
country: United States
facility: Orthopaedic Medical Group of Tampa Bay PA
state: Florida
city: Temple Terrace
country: United States
facility: Foundation for Orthopaedic Research and Eduation
state: Florida
city: Louisville
country: United States
facility: Norton Orthopaedics and Sports Medicine
state: Kentucky
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: ryan.boylan@zimmerbiomet.com
name: Ryan Boylan
role: STUDY_DIRECTOR
References: