Trial Comparing Treatment Strategies in Triangular Fibrocartilage Complex Ruptures
NCT ID: NCT04576169
Last Updated: 2024-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
204 participants
INTERVENTIONAL
2020-10-27
2035-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Central or Radial Tear: Arthroscopic debridement
Arthroscopic debridement
Arthroscopic Debridement
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.
Central or Radial Tear: Sham surgery
Diagnostic arthroscopy only (placebo surgery).
Placebo surgery
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.
Ulnar Tear: Arthroscopic or open repair
Arthroscopic or open repair
Arthroscopic or Open Repair
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.
Ulnar Tear: Physiotherapy
Diagnostic arthroscopy and physiotherapy
Physiotherapy
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.
Interventions
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Arthroscopic Debridement
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.
Placebo surgery
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.
Arthroscopic or Open Repair
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.
Physiotherapy
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
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
65 Years
ALL
No
Sponsors
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Helsinki University Central Hospital
OTHER
Turku University Hospital
OTHER_GOV
Kuopio University Hospital
OTHER
Oulu University Hospital
OTHER
Karolinska Institutet
OTHER
Hospital Sønderjylland
UNKNOWN
Copenhagen University Hospital at Herlev
OTHER
Hospital Nova of Central Finland
UNKNOWN
Tampere University Hospital
OTHER
Responsible Party
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Jarkko Jokihaara
Associate professor of hand surgery
Principal Investigators
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Antti Kaivorinne, M.D.
Role: PRINCIPAL_INVESTIGATOR
Tampere University Hospital
Mikko P Räisänen, M.D.
Role: PRINCIPAL_INVESTIGATOR
Tampere University Hospital
Teemu Karjalainen, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Hospital Nova of Central Finland
Aleksi Reito, M.D., Ph.D., Adjunct professor
Role: PRINCIPAL_INVESTIGATOR
Tampere University Hospital
Robert Gvozdenovic, M.D., Ph. D.
Role: PRINCIPAL_INVESTIGATOR
Copenhagen University Hospital at Herlev
Maria Wilcke, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Turkka Anttila, M.D.
Role: PRINCIPAL_INVESTIGATOR
Helsinki University Central Hospital
Annele Pönkkö, M.D.
Role: PRINCIPAL_INVESTIGATOR
Oulu University Hospital
Jerzy Stiasny, M.D.
Role: PRINCIPAL_INVESTIGATOR
Hospital Sønderjylland
Tuukka Tanskanen, M.D.
Role: PRINCIPAL_INVESTIGATOR
Turku University Hospital
Locations
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Herlev/Gentofte University Hospital of Copenhagen
Copenhagen, , Denmark
Hospital Sønderjylland
Sønderborg, , Denmark
Hospital Nova of Central Finland
Jyväskylä, Central Finland, Finland
Oulu University Hospital
Oulu, North Ostrobothnia, Finland
Kuopio University Hospital
Kuopio, Northern Savonia, Finland
Tampere University Hospital
Tampere, Pirkanmaa, Finland
Turku University Hospital
Turku, Southwest Finland, Finland
Helsinki University Hospital
Helsinki, Uusimaa, Finland
Karolinska University Hospital
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Jerzy Stiasny, M.D.
Role: primary
Matti-Aleksi Mosorin, M.D.
Role: backup
References
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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.
Other Identifiers
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Tampere University Hospital
Identifier Type: -
Identifier Source: org_study_id
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