Comparing two techniques for repairing large rotator cuff tears
A Clinical Research on Arthroscopic Repair of Massive-large Rotator Cuff Tears With a Novel Inner Fixation Technique
This study is testing two different surgical techniques for fixing large rotator cuff tears to see which one helps people recover better after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 17 Years to 75 Years |
| Sex | All |
| Sponsor | Peking University Third Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05214651 on ClinicalTrials.gov |
What this trial studies
This clinical research aims to compare the effectiveness of a novel double row technique against a suture bridge double row technique in the arthroscopic repair of massive-large rotator cuff tears. A total of 52 participants will be enrolled and randomly assigned to one of the two techniques. Functional outcomes will be assessed preoperatively and at 3, 6, 12, and 24 months post-surgery using various scoring systems and pain scales. Additionally, anatomical outcomes will be evaluated through MRI at the same intervals to determine the success of the repairs.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 17 to 75 with a confirmed diagnosis of a large-massive rotator cuff tear greater than 3 cm.
Not a fit: Patients with irreparable tears, severe arthritis, or those who have had previous shoulder surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques and outcomes for patients with large rotator cuff tears.
How similar studies have performed: While this approach is novel, similar studies have shown promising results in improving surgical outcomes for rotator cuff repairs.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing Municipality
- Institute of Sports Medicine, Peking University Third Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Ping Liu, M.D. — Institute of Sports Medicine, Peking University Third Hospital
- Study coordinator: Ping Liu, M.D.
- Email: bjusmlp@126.com
- Phone: 01082267020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.