Microfracture technique to improve healing of rotator cuff tears
Randomized Controlled Trial of Patients Treated With and Without Lateralized Microfracture During Rotator Cuff Repair
This study tests if a new microfracture technique can help people with medium to large rotator cuff tears heal better after surgery compared to standard repair methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Affiliated Hospital of Nantong University Academic / other |
| Locations | 2 sites (Nantong, Jiangsu and 1 other locations) |
| Trial ID | NCT05624164 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of lateralized microfracture on the healing of medium to large rotator cuff tears following arthroscopic repair. Participants will be randomly assigned to receive either the microfracture treatment or conventional repair without microfracture. The study aims to determine if this technique can reduce the rate of retear and enhance functional recovery post-surgery. The trial focuses on patients who have not responded to non-operative treatment for at least three months.
Who should consider this trial
Good fit: Ideal candidates are individuals with medium to large rotator cuff tears (1cm-5cm) who have failed non-operative treatment.
Not a fit: Patients with small or massive rotator cuff tears, revision surgeries, or irreparable tears may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved healing outcomes and reduced retear rates for patients with rotator cuff tears.
How similar studies have performed: While the concept of microfracture is established in other orthopedic contexts, this specific application for rotator cuff repair is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Medium to large Rotator cuff tear(1cm-5cm) diagnosed by MRI 2. Patients can complete the follow-up and comply with all post-operative rehab instructions 3. Failure of non-operative treatment for at least 3 months Exclusion Criteria: 1. Revision rotator cuff surgery 2. Partial thickness rotator cuff tears 3. Small (less than 1cm) and Massive (greater than 5cm) rotator cuff tears 4. Disease history of the affected shoulder 5. Systemic immune diseases 6. Irreparable rotator cuff tear
Where this trial is running
Nantong, Jiangsu and 1 other locations
- Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (Not_yet_recruiting)
- Afiliated Hospital of Nantong University — Nantong, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Yucheng Sun, Ph.D — Affiliated Hospital of Nantong University
- Study coordinator: Mingbing Xiao, Ph.D
- Email: tdfykjc@163.com
- Phone: +86051381162222
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.