Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-21 @ 9:48 PM
Study NCT ID:
NCT04576169
Status:
RECRUITING
Last Update Posted:
2024-10-09
First Post:
2020-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial Comparing Treatment Strategies in Triangular Fibrocartilage Complex Ruptures
Sponsor:
Tampere University Hospital
Organization:
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 1:1 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 1:1 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 arthroscopic/open 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 patient's 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 1:1 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 arthroscopic/open 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 patient's 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:
True
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?:
False
Is an FDA AA801 Violation?: