Trials / Unknown
UnknownNCT04618484
Biomodulating Rotator Cuff Healing - A Proof of Concept Trial
Can Non-pharmacological BIOmodulation Improve Healing After Arthroscopic Rotator Cuff Repair Using a Knotted Suturebridge Technique?
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 146 (estimated)
- Sponsor
- Clinique Générale dAnnecy · Academic / Other
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Biomodulation (non-pharmacological) | cryo-, photo- and electro-biomodulation |
Timeline
- Start date
- 2021-12-01
- Primary completion
- 2024-05-01
- Completion
- 2024-12-01
- First posted
- 2020-11-06
- Last updated
- 2023-07-03
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04618484. Inclusion in this directory is not an endorsement.