Trial Comparing Treatment Strategies in Triangular Fibrocartilage Complex Ruptures
REINFORCER
TREatment of Triangular FibrOcaRtilage ComplEx Ruptures (REINFORCER): Protocol for Randomized, Controlled, Blinded, Efficacy Trial of Triangular Fibrocartilage Complex Tears
1 other identifier
interventional
204
3 countries
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2020
CompletedFirst Posted
Study publicly available on registry
October 6, 2020
CompletedStudy Start
First participant enrolled
October 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2035
October 9, 2024
October 1, 2024
7.4 years
September 29, 2020
October 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient-Rated Wrist Evaluation (PRWE)
The PRWE questionnaire is a wrist-specific instrument comprising a 15-item questionnaire assessing pain and disability in daily living. PRWE provides a score ranging from 0 (best) to 100 (worst). This wrist-specific tool demonstrates good reliability, validity, and responsiveness. Translation and validation have been conducted for Danish, Finnish, and Swedish languages. In interpreting the results, we will employ the Minimally Important Difference (MID) value of 14. PRWE as secondary outcome will be measured at all the other time points (6 months, 2, 5 and 10 years) than primary outcome.
10 year follow-up, primary time point at 1 year
Secondary Outcomes (6)
Quality of life (EQ-5D-3L)
10 year follow-up
Adverse and serious adverse events
10 year follow-up
Global improvement
10 year follow-up
Pain in activity
10 year follow-up
Grip strength
2 year follow-up
- +1 more secondary outcomes
Study Arms (4)
Central or Radial Tear: Arthroscopic debridement
EXPERIMENTALArthroscopic debridement
Central or Radial Tear: Sham surgery
PLACEBO COMPARATORDiagnostic arthroscopy only (placebo surgery).
Ulnar Tear: Arthroscopic or open repair
EXPERIMENTALArthroscopic or open repair
Ulnar Tear: Physiotherapy
ACTIVE COMPARATORDiagnostic arthroscopy and physiotherapy
Interventions
Wrist arthroscopy can be performed with or without irrigation. In the debridement arm, a central or radial TFCC tear found during arthroscopy is debrided with a shaver. Portals are closed either with sutures or with medical tape. Immediate mobilization of the wrist is allowed after the operation. Participants are provided with instructions for home exercises, and they are advised to commence the exercises two weeks post-operation.
Diagnostic wrist arthroscopy can be performed with or without irrigation. A central or radial TFCC tear found during wrist arthroscopy is left untouched and no other operative interventions are done. Portals are closed either with sutures or with medical tape. The procedure is performed in general or regional anesthesia in operating room. Participants are not able to see to the operation area or monitor. They will listen to music with noise-cancelling headphones throughout the operation. The operative time will be matched, with the surgeon simulating a debridement procedure. Immediate mobilization of the wrist is allowed after the operation. Participants are provided with instructions for home exercises, and they are advised to commence the exercises two weeks post-operation.
An ulnar TFCC tear found during wrist arthroscopy is sutured to the capsule or fovea with one of the separately defined methods choosed by the treating hand surgeon. The procedure is performed in general or regional anesthesia in operating room. Wounds are closed and standardized post-operative treatment is started after six weeks.
An ulnar TFCC tear found during wrist arthroscopy is left untouched and no other operative interventions are done. Portals are closed with sutures or medical tape. The procedure is performed in general or regional anesthesia in operating room. Physiotherapy exercises of wrist and DRUJ stabilizers is started after two weeks.
Eligibility Criteria
You may qualify if:
- Ulnar sided wrist pain
- Age more than 18 years
- Suspicion of TFCC tear in clinical examination
- Ability to fill the Danish, Finnish or Swedish versions of questionnaires
- Symptom duration more than 3 months, and unsuccessful non-operative treatment
- Central (Palmer 1A), ulnar (Palmer 1B) or radial (Palmer 1D) TFCC tear explaining the pain in arthroscopy
You may not qualify if:
- Gross instability of DRUJ which will be defined as "obvious instability in clinical examination in each forearm and wrist position"
- Distal (Palmer 1C) TFCC tear in arthroscopy
- Ulnocarpal or DRUJ arthrosis (Atzei class 5)
- Ulnar variance ≥ +2 mm in x-ray
- Age above 65 years
- Rheumatoid arthritis or other inflammatory disease effecting radio- or ulnocarpal or DRUJ
- Lunotriquetral instability diagnosed in arthroscopy
- ECU instability
- Massive tear and degenerated edges or frayed tear which fails suture (Atzei class 4A-4B)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tampere University Hospitallead
- Helsinki University Central Hospitalcollaborator
- Turku University Hospitalcollaborator
- Kuopio University Hospitalcollaborator
- Oulu University Hospitalcollaborator
- Karolinska Institutetcollaborator
- Hospital Sønderjyllandcollaborator
- Copenhagen University Hospital at Herlevcollaborator
- Hospital Nova of Central Finlandcollaborator
Study Sites (9)
Herlev/Gentofte University Hospital of Copenhagen
Copenhagen, 2900, Denmark
Hospital Sønderjylland
Sønderborg, Denmark
Hospital Nova of Central Finland
Jyväskylä, Central Finland, 40620, Finland
Oulu University Hospital
Oulu, North Ostrobothnia, 90220, Finland
Kuopio University Hospital
Kuopio, Northern Savonia, 70029, Finland
Tampere University Hospital
Tampere, Pirkanmaa, 33521, Finland
Turku University Hospital
Turku, Southwest Finland, 20521, Finland
Helsinki University Hospital
Helsinki, Uusimaa, 00029, Finland
Karolinska University Hospital
Stockholm, 171 76, Sweden
Related Publications (1)
Kaivorinne A, Raisanen MP, Karjalainen T, Jokihaara J, Gvozdenovic R, Wilcke M, Reito A, Anttila T, Ponkko A, Lauridsen C, Tanskanen T, Mattila VM; REINFORCER investigators. tREatment of trIaNgular FibrOcaRtilage ComplEx Ruptures (REINFORCER): protocol for randomised, controlled, blinded, efficacy trial of triangular fibrocartilage complex tears. BMJ Open. 2024 Dec 11;14(12):e086102. doi: 10.1136/bmjopen-2024-086102.
PMID: 39663172DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antti Kaivorinne, M.D.
Tampere University Hospital
- PRINCIPAL INVESTIGATOR
Mikko P Räisänen, M.D.
Tampere University Hospital
- PRINCIPAL INVESTIGATOR
Teemu Karjalainen, M.D., Ph.D.
Hospital Nova of Central Finland
- PRINCIPAL INVESTIGATOR
Aleksi Reito, M.D., Ph.D., Adjunct professor
Tampere University Hospital
- PRINCIPAL INVESTIGATOR
Robert Gvozdenovic, M.D., Ph. D.
Copenhagen University Hospital at Herlev
- PRINCIPAL INVESTIGATOR
Maria Wilcke, M.D., Ph.D.
Karolinska Institutet
- PRINCIPAL INVESTIGATOR
Turkka Anttila, M.D.
Helsinki University Central Hospital
- PRINCIPAL INVESTIGATOR
Annele Pönkkö, M.D.
Oulu University Hospital
- PRINCIPAL INVESTIGATOR
Jerzy Stiasny, M.D.
Hospital Sønderjylland
- PRINCIPAL INVESTIGATOR
Tuukka Tanskanen, M.D.
Turku University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Operating surgeon, operating theatre staff, coordinating research assistant (CRA), and research assistants (RA) cannot be blinded to the allocation. In central or radial tear randomization cohort, outcome assessors will be blinded and they will not participate in the care at any other point in the trial, except during follow-up visits. The participants are also blinded, resulting in a triple-blinded randomization cohort since also trialist are blinded in data analysis phase as in foveal tear randomization cohort. In the ulnar tear cohort, randomization cannot be blinded due to differing postoperative treatment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor of hand surgery
Study Record Dates
First Submitted
September 29, 2020
First Posted
October 6, 2020
Study Start
October 27, 2020
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
March 31, 2035
Last Updated
October 9, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be available after the publication and it will be available for 15 years.
- Access Criteria
- By request.
All the IPD will be shared with other researchers by request.