New approach to improve healing of rotator cuff tears
Can Non-pharmacological BIOmodulation Improve Healing After Arthroscopic Rotator Cuff Repair Using a Knotted Suturebridge Technique?
This study is testing a new rehabilitation method using different types of light and electrical treatments to see if it helps people heal better after surgery for rotator cuff tears compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 146 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Clinique Générale dAnnecy Academic / other |
| Locations | 1 site (Annecy) |
| Trial ID | NCT04618484 on ClinicalTrials.gov |
What this trial studies
This trial investigates a novel non-pharmacological rehabilitation protocol aimed at enhancing the healing of full-thickness rotator cuff tears after arthroscopic repair. A total of 146 patients will be randomly assigned to either a biomodulation treatment group, which includes cryo-, photo-, and electro-biomodulation, or a control group that will use a standard immobilization method. The effectiveness of the intervention will be assessed through MRI evaluations at one year post-surgery, using the Sugaya classification to determine healing outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with symptomatic full-thickness rotator cuff tears and no significant muscle atrophy or fatty infiltration.
Not a fit: Patients with partial tears, irreparable tears, or significant comorbidities affecting surgery outcomes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce retear rates and improve recovery outcomes for patients with rotator cuff tears.
How similar studies have performed: While this approach is innovative, similar biomodulation techniques have shown promise in other contexts, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * Patient is over 18 years old * Patient presents with a symptomatic full-thickness tear as diagnosed preoperatively on ultrasound, arthro-CT or MRI. * Absence of significant muscle atrophy or fatty infiltration of the affected tendon exceeding stage 2 of the Goutallier classification Exclusion criteria * Partial rotator cuff tear or other shoulder injury * Planned concomitant procedures other than subacromial decompression, acromioclavicular joint resection or biceps tenodesis/tenotomy * Irreparable rotator cuff tear * Patients who present with cartilage lesions greater than stage II of the Outerbridge classification (≥15mm diameter) on preoperative x-ray * Patient presenting with a known comorbidity that could affect the outcome of surgery (cervical radiculopathy, polyarthritis, neurological disease of the upper limb) * Patient not able to give informed consent
Where this trial is running
Annecy
- Clinique Générale d'Annecy — Annecy, France (Recruiting)
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.