Biomodulating healing after arthroscopic rotator cuff repair: the protocol of a randomised proof of concept trial (BIOHACK)

Purpose/introduction Over the last decades, there has been increasing interest in biological stimulation or bioaugmentation after rotator cuff repair. So far, there is no consensus on the appropriate composition of biologicals or which patients would benefit most, and moreover, these biologicals are often expensive. However, there are other, non-pharmacological strategies that are also believed to achieve biological stimulation. This randomised controlled trial evaluates the possible cumulative effect of pragmatic application of cryobiomodulation, photobiomodulation and electrobiomodulation—collectively called biomodulation—on the bone-to-tendon healing process after rotator cuff repair. Methods In this randomised, controlled proof of concept study, 146 patients undergoing arthroscopic repair of a full thickness posterosuperior or anterosuperior rotator cuff tear will be 1:1 randomly assigned to either a control group or to the additional biomodulation protocol group. The adjuvant biomodulation protocol consists of seven self-applicable therapies and will be administered during the first 6 weeks after surgery. Primary outcome will be healing of the rotator cuff as evaluated by the Sugaya classification on MRI at 1-year postoperatively. Ethics and dissemination This study has been accepted by the National Ethical Review Board CPP Sud-Est IV in France and has been registered at Clinicaltrials.gov. The results of this study will be published in a peer-reviewed journal. Trial registration number NCT04618484.