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Biomodulating Rotator Cuff Healing - A Proof of Concept Trial

NCT04618484 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2023-07-03

No results posted yet for this study

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

Interventions

OTHER

Biomodulation (non-pharmacological)

cryo-, photo- and electro-biomodulation

Sponsors & Collaborators

  • Clinique Générale dAnnecy

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2024-05-31
Completion
2024-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04618484 on ClinicalTrials.gov