NCT04618484|Unknown
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?
Loading search results
BIOHACK
Can Non-pharmacological BIOmodulation Improve Healing After Arthroscopic Rotator Cuff Repair Using a Knotted Suturebridge Technique?
Sponsor study identifier
interventional
146
1 country
1
Study Start
December 1, 2021
Actual (reported)Primary Completion
May 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2020
Actual (reported)November 6, 2020
Actual (reported)December 1, 2021
Actual (reported)May 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Healing of rotator cuff tear
Healing will be evaluated using the Sugaya classification on MRI
1 year post-operatively
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
6-weeks post-operative cryo-, photo- and electro-biomodulation protocol after repair
standard rehabilitation after repair
cryo-, photo- and electro-biomodulation
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Clinique Générale d'Annecy
Annecy, France
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.
First Submitted
November 1, 2020
First Posted
November 6, 2020
Study Start
December 1, 2021
Actual (reported)Primary Completion
Superior Capsular Reconstruction Versus. Partial Repair for Irreparable Rotator Cuff Tears
Contact the study team to confirm eligibility.
May 2024
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 3, 2023
Record last verified: 2023-06
Due to privacy reasons individual patient data will not be available to the public.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: