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.

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: Other: Biomodulation (non-pharmacological)

• Study Type: Interventional
• Enrollment (Estimated): 146
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Annecy, France
    • Recruiting
    • Clinique Générale d'Annecy
    • Contact: Geert-Alexander BUIZJE, MD; Email: gabuijze@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biomodulation; 6-weeks post-operative cryo-, photo- and electro-biomodulation protocol after repair	Other: Biomodulation (non-pharmacological); cryo-, photo- and electro-biomodulation
No Intervention: Control; standard rehabilitation after repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing of rotator cuff tear	Healing will be evaluated using the Sugaya classification on MRI	1 year post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported outcome measures	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	6 months and 1 year
Active range of motion	Degrees of forward flexion, abduction, internal rotation and external rotation (90 degrees elbow flexion, 0 and 90 degrees abduction)	6 months and 1 year
Compliance	Self-reported daily compliance to the different components of the biomodulation protocol	First 6 weeks after surgery
Postoperative complications	Postoperative complications in the first year after surgery	First year after surgery

Collaborators and Investigators

• Sponsor: Clinique Générale dAnnecy

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 1, 2020
• First Submitted That Met QC Criteria: November 1, 2020
• First Posted (Actual): November 6, 2020

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 29, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 2020BIOHACK-trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to privacy reasons individual patient data will not be available to the public.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No