Biomodulating Rotator Cuff Healing - A Proof of Concept Trial

NCT04618484 | Unknown

• 1 other identifier: 2020BIOHACK-trial
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tears

Outcome Measures

Primary Outcomes (1)

• Healing of rotator cuff tear

  Healing will be evaluated using the Sugaya classification on MRI

  1 year post-operatively

Secondary Outcomes (4)

• Patient reported outcome measures

  6 months and 1 year

• Active range of motion

  6 months and 1 year

• Compliance

  First 6 weeks after surgery

• Postoperative complications

  First year after surgery

Study Arms (2)

Biomodulation

EXPERIMENTAL

6-weeks post-operative cryo-, photo- and electro-biomodulation protocol after repair

Other: Biomodulation (non-pharmacological)

Control

NO INTERVENTION

standard rehabilitation after repair

Interventions

Biomodulation (non-pharmacological) OTHER

cryo-, photo- and electro-biomodulation

Biomodulation

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique Générale dAnnecy: lead

Study Sites (1)

Clinique Générale d'Annecy

Annecy, France

RECRUITING

Related Publications (1)

• Allaart LJH, Lech J, Macken AA, Kling A, Lafosse L, Lafosse T, van den Bekerom MPJ, Buijze GA. Biomodulating healing after arthroscopic rotator cuff repair: the protocol of a randomised proof of concept trial (BIOHACK). BMJ Open. 2023 Aug 16;13(8):e071078. doi: 10.1136/bmjopen-2022-071078.

  PMID: 37586862 DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon

Model Details: RCT

Study Record Dates

• First Submitted: November 1, 2020
• First Posted: November 6, 2020
• Study Start: December 1, 2021
• Primary Completion: May 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)