Biomodulating Rotator Cuff Healing - A Proof of Concept Trial (BIOHACK)

Can Non-pharmacological BIOmodulation Improve Healing After Arthroscopic Rotator Cuff Repair Using a Knotted Suturebridge Technique?

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.

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

Degrees of forward flexion, abduction, internal rotation and external rotation (90 degrees elbow flexion, 0 and 90 degrees abduction)

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