NCT05214651 A Clinical Research on Repair of Massive-large Rotator Cuff Tears
| NCT ID | NCT05214651 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University Third Hospital |
| Condition | Rotator Cuff Tears |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2022-06-08 |
| Primary Completion | 2026-05 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The study is designed as a randomized controlled trial, a total of 52 participants with large - massive rotator cuff tears will be prospectively enrolled and randomly divided into 2 groups according to the applied repairing technique: novel double row technique group and suture bridge double row technique group. The functional outcome was measured at the preoperatively, 3, 6, 12 and 24 months postoperatively, using the visual analog scale (VAS) for pain, active and passive ROM, Constant score, American Shoulder and Elbow Surgeons (ASES) score, and University of California Los Angeles shoulder score (UCLA). The anatomic outcome was evaluated using magnetic resonance imaging at 3, 6, 12 and 24 months postoperatively. The clinical results were compared between the novel double row technique group and suture bridge double row technique group.
Eligibility Criteria
Inclusion Criteria: * preoperative magnetic resonance imaging (MRI) diagnosis of a large - massive sized rotator cuff tear (\>3cm), which was confirmed during operation * chronic tear * older than 17 years and younger than 75 years * without surgical contraindications and willing to participate Exclusion Criteria: * poor quality rotator cuff and irreparable tear * severe glenohumeral arthritis * previous shoulder surgery * accompanied by dislocation or fracture of shoulder * refusal to participate