Rotator Cuff Tears
Conditions
Brief summary
Novel concepts in quantum biology of rotator cuff repair and author's novel findings on biomodulation inspired us to design a pragmatic non-pharmacological add-on rehabilitation protocol that may potentially decrease retear rates after arthroscopic repair using a knotted suturebridge technique. In this proof-of-concept trial, 146 patients will be randomized 1:1 to either a 6-weeks post-operative cryo-, photo- and electro-biomodulation protocol or a control group immobilized in a standard abduction sling for 6 weeks. Healing will be evaluated using the Sugaya classification on MRI at 1 year post-operatively.
Interventions
OTHERBiomodulation (non-pharmacological)
cryo-, photo- and electro-biomodulation
Sponsors
Clinique Générale dAnnecy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
RCT
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing of rotator cuff tear | 1 year post-operatively | Healing will be evaluated using the Sugaya classification on MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported outcome measures | 6 months and 1 year | Pain, reported as average of reported pain during movement, at rest and at night, measured by a numeric rating scale from 0 to 10; and the Auto-Constant score, Subjective Shoulder Value, the American Shoulder and Elbow Surgeon score Surgeon score |
| Active range of motion | 6 months and 1 year | Degrees of forward flexion, abduction, internal rotation and external rotation (90 degrees elbow flexion, 0 and 90 degrees abduction) |
| Compliance | First 6 weeks after surgery | Self-reported daily compliance to the different components of the biomodulation protocol |
| Postoperative complications | First year after surgery | Postoperative complications in the first year after surgery |
Countries
France
Outcome results
None listed