Ignite Creation Date:
2024-05-06 @ 3:16 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04576169
Status:
RECRUITING
Last Update Posted:
2021-08-31
First Post:
2020-09-29
Brief Title:
Trial Comparing Treatment Strategies in Triangular Fibrocartilage Complex Ruptures
Sponsor:
Tampere University Hospital
Organization:
Tampere University Hospital
Study Overview
Official Title:
TREatment of Triangular FibrOcaRtilage ComplEx Ruptures REINFORCER Protocol for Randomized Controlled Blinded Efficacy Trial of Triangular Fibrocartilage Complex Tears
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REINFORCER
Brief Summary:
The trial is a multicentre randomized superiority controlled participant and outcome assessor debridement versus placebo surgery randomization cohort and trialist blinded both arms superiority umbrella trial with two randomized cohorts 1 debridement or placebo surgery 2 repair or physiotherapy which both include two 11 parallel arms The primary objective is to investigate the superiority of 1 debridement over placebo surgery and 2 repair over physiotherapy in two randomized cohorts using Patient-Rated Wrist Evaluation PRWE at one year post randomisation as the primary outcome
Detailed Description:
Triangular fibrocartilage complex TFCC injuries are often considered the cause of ulnar wrist pain TFCC lesions can be traumatic or degenerative according to classification suggested by Palmer and Atzei Primary treatment is conservative but if symptoms persist operative treatment is an option Depending on the morphology of the tear the treatment can be either debridement or repair Trialists have observed improvement of symptoms after TFCC repair but all these trials are observational cohorts without proper controls Efficacy of surgery has not been studied in randomized controlled trial RCT setting
The investigators planned a multicentre randomized superiority controlled participant and outcome assessor debridement versus placebo surgery randomisation cohort and trialist blinded both arms superiority umbrella trial with two randomized cohorts which both include two 11 parallel arms Participants in the first cohort central or radial TFCC tear will undergo randomization to either arthroscopic debridement or placebo surgery In the second cohort peripheral TFCC tear participants will be randomized to arthroscopicopen TFCC repair or physiotherapy Our primary objective is to investigate the superiority of 1 debridement over placebo surgery for central Palmer 1A and radial Palmer 1D TFCC tears and 2 repair over non-operative treatment physiotherapy for ulnar Palmer 1B TFCC tears in two randomized cohorts using Patient-Rated Wrist Evaluation PRWE at one year post randomisation as the primary outcome
Institutional Review Board IRB of Tampere university hospital has approved the study protocol All participants will give written informed consent The results of the trial will be disseminated as published articles in peer-reviewed journals
Outcome measures for different studies are often derived from what clinicians rather than patients thinks to be important The investigators chose to base the efficacy assessment on the measure of patients subjective disability and pain
There is no clear evidence of the efficacy of the treatments debridement and repair It is justified and ethically correct to compare these treatments to placebo surgery and physiotherapy Placebo surgery and physiotherapy are less invasive than debridement and repair and because of this are even safer to patients than comparable treatments
The investigators planned a multicentre randomized superiority controlled participant and outcome assessor debridement versus placebo surgery randomisation cohort and trialist blinded both arms superiority umbrella trial with two randomized cohorts which both include two 11 parallel arms Participants in the first cohort central or radial TFCC tear will undergo randomization to either arthroscopic debridement or placebo surgery In the second cohort peripheral TFCC tear participants will be randomized to arthroscopicopen TFCC repair or physiotherapy Our primary objective is to investigate the superiority of 1 debridement over placebo surgery for central Palmer 1A and radial Palmer 1D TFCC tears and 2 repair over non-operative treatment physiotherapy for ulnar Palmer 1B TFCC tears in two randomized cohorts using Patient-Rated Wrist Evaluation PRWE at one year post randomisation as the primary outcome
Institutional Review Board IRB of Tampere university hospital has approved the study protocol All participants will give written informed consent The results of the trial will be disseminated as published articles in peer-reviewed journals
Outcome measures for different studies are often derived from what clinicians rather than patients thinks to be important The investigators chose to base the efficacy assessment on the measure of patients subjective disability and pain
There is no clear evidence of the efficacy of the treatments debridement and repair It is justified and ethically correct to compare these treatments to placebo surgery and physiotherapy Placebo surgery and physiotherapy are less invasive than debridement and repair and because of this are even safer to patients than comparable treatments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None