Combined microfracture procedure for healing rotator cuff tears
Combined Microfracture Procedure Promotes Tendon Healing During Double Raw Repair for Full Tear Rotator Cuff - a Prospective Randomized Study With 2-year Follow-up
This study is testing if a new combined surgery technique can help people with full rotator cuff tears heal better than the standard surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 20 Years to 60 Years |
| Sex | All |
| Sponsor | Beijing Jishuitan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05792202 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a combined microfracture procedure in promoting tendon healing during double raw repair for patients with full rotator cuff tears. Participants are randomly assigned to different treatment groups and followed up at various intervals post-surgery to assess pain, functional scores, muscle strength, and MRI results. The goal is to compare the outcomes of the combined procedure against standard double raw repair. This prospective randomized controlled design aims to provide robust evidence on the best treatment approach for rotator cuff injuries.
Who should consider this trial
Good fit: Ideal candidates are young and middle-aged individuals aged 20 to 60 with unilateral small to medium full rotator cuff tears confirmed by arthroscopy.
Not a fit: Patients with previous shoulder surgeries, bilateral injuries, or other significant shoulder conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve healing outcomes and recovery for patients with rotator cuff tears.
How similar studies have performed: While this specific approach is novel, similar studies have shown promising results in tendon healing with microfracture techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Arthroscopy confirmed small to medium full rotator cuff tear * Unilateral rotator cuff injury * Voluntarily accept randomized controlled grouping, cooperate with treatment and follow up patients * Young and middle-aged patients aged 20 to 60 Exclusion Criteria: * Previous shoulder surgery (incision or arthroscopy) * Combined with diseases of other parts of the same limb * Combined with Bankart injury, acromioclavicular joint disease, greater tuberosity fracture, glenoid fracture and so on * Bilateral onset * Unable or unwilling to receive clinical follow-up
Where this trial is running
Beijing, Beijing Municipality
- Beijing Jishuitan hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Shangzhe Li, M.D.
- Email: 562744381@qq.com
- Phone: +86 13826162999
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.