Biomodulating Rotator Cuff Healing - A Proof of Concept Trial

Rotator Cuff Tears Clinical Trial

— BIOHACK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04618484
• Other study ID #: 2020BIOHACK-trial
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: June 2023
• Source: Clinique Générale dAnnecy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 146
• Est. completion date: December 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

Other:
• Biomodulation (non-pharmacological)
cryo-, photo- and electro-biomodulation

Locations

Country	Name	City	State
France	Clinique Générale d'Annecy	Annecy

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Générale dAnnecy

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing of rotator cuff tear	Healing will be evaluated using the Sugaya classification on MRI	1 year post-operatively
Secondary	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
Secondary	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
Secondary	Compliance	Self-reported daily compliance to the different components of the biomodulation protocol	First 6 weeks after surgery
Secondary	Postoperative complications	Postoperative complications in the first year after surgery	First year after surgery