💬In plain words
What the trial is, and whether it could suit you
The overall objective of this clinical investigation is to assess the safety and efficacy of full-thickness arthroscopic rotator cuff repairs augmented with the FiberLocker System for the subjects. The primary outcome of the investigation is to assess the safety after full-thickness arthroscopic rotator cuff repairs augmented with the FiberLocker System in terms of postoperative adverse events through the 12-month follow-up. Main secondary outcomes include measures of efficacy and clinical performance evaluated at 6-week, 4.5-month, and 12-month follow-ups including retear rate assessed using MRI and different functional performance scores.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Subject requires surgical treatment of a full-thickness rotator cuff tear, according to Balgrist standard procedure
2. Full-thickness tear of the supraspinatus or combined infraspinatus and supraspinatus
3. The rotator cuff tear is of traumatic origin.
4. Subject is ≥ 40 years of age \& ≤ 65 years of age.
5. Primary rotator cuff repair
6. Informed Consent signed by the subject
7. Pre-operative MRI performed
Exclusion Criteria:
1. Vulnerable subjects (as defined in ISO 14155)
2. Subjects who do not have the power of judgement or are unable to fully understand all aspects of the investigation that are relevant to the decision to participate
3. Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation,
4. Previous enrolment into the current investigation,
5. Enrolment of the PI, his/her family members, employees and other dependent persons,
6. Inability to follow the procedures of the investigation, or known or suspected non-compliance, e.g. due to language problems, psychological disorders, dementia, drug or alcohol abuse, etc. of the subject
7. Active smoker
8. History of claustrophobia that would prevent an MRI of the index shoulder
9. Presence of an implanted metallic device or other implants that would contraindicate acquisition or inhibit radiologist review of an MRI of the index shoulder
10. Pregnant or planning to become pregnant during the study period
11. Breast feeding women
12. Subject has conditions or circumstances that would interfere with study requirements.
13. Contraindications and limitations of the MD as described in the IFUs.
14. Partial rotator cuff tears
15. History or known allergy or intolerance to polyester
16. Complete full-thickness subscapularis tears greater than the superior 1/3 of the tendon, with Lafosse grade 3 or greater
17. Massive rotator cuff tears, tear size equal to or greater than 4 cm in the anterior-posterior dimension or irreparable rotator cuff tear
18. Limited space or exposure for implant delivery
19. Structural or pathological condition of the bone or soft tissue that could impair healing.
20. Intraoperative rotator cuff tear characteristics differ from preoperatively expected characteristics and fulfil one of the abovementioned criteria
21. Fatty infiltration of the index shoulder rotator cuff muscle \> Goutallier Score 2
22. Corticosteroid injection in the operative shoulder within 6 weeks of operation
23. Subject shows frozen shoulder/adhesive capsulitis at day of surgery
24. Cases of moderate to severe osteoarthritis
25. Patients with inflammatory disease or auto-immune based joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, arthropathy)
26. Subjects with diabetes type I or II
27. The subject currently has an acute infection in the area surrounding the surgical site
28. Evidence of active infection, osteomyelitis, sepsis or distant infection which could spread to the index joint.
29. Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator.
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