Principal Investigator: Robert Tashjian
Keywords: BioWick , Zimmer-Biomet , Rotator cuff , Suture anchor Department: Orthopedic Surgery Operations
IRB Number: 00112041 Co Investigator: Peter Chalmers
Specialty: Orthopaedic Surgery
Sub Specialties: Upper Extremity
Recruitment Status: Completed

Contact Information

Victoria Childress
vchildress@hsc.utah.edu
8015872353

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.

The primary objective of this study is to assess survivorship (lack of reoperation/device removal) with the use of the BioWick SureLock implant.

 

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.

 

Inclusion 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

Any subject who meets any of the exclusion criteria will be excluded from participation in this study:

  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 post-operative 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;