tREatment of trIaNgular FibrOcaRtilage ComplEx Ruptures (REINFORCER): protocol for randomised, controlled, blinded, efficacy trial of triangular fibrocartilage complex tears
Introduction Triangular fibrocartilage complex (TFCC) tear is often considered to be the cause of ulnar wrist pain. The primary treatment typically involves non-operative methods; however, in cases of persistent symptoms, operative intervention has been proposed as a viable option. Depending on the...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2024-12-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/12/e086102.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850114755937697792 |
|---|---|
| author | Teemu Karjalainen Jarkko Jokihaara Ville M Mattila Aleksi Reito Antti Kaivorinne Toni Luokkala Mikko Petteri Räisänen Robert Gvozdenovic Maria Wilcke Turkka Anttila Annele Pönkkö Carsten Lauridsen Tuukka Tanskanen Matti Juntunen Olli-Pekka Kangasniemi Morten Kjaer Heli Lähdeniemi Panu Nordback Shabir Rashidi Janne Soikkeli Jerzy Stiasny Elin Sward Lars Vadstrup Johanna Vonkieseritzky |
| author_facet | Teemu Karjalainen Jarkko Jokihaara Ville M Mattila Aleksi Reito Antti Kaivorinne Toni Luokkala Mikko Petteri Räisänen Robert Gvozdenovic Maria Wilcke Turkka Anttila Annele Pönkkö Carsten Lauridsen Tuukka Tanskanen Matti Juntunen Olli-Pekka Kangasniemi Morten Kjaer Heli Lähdeniemi Panu Nordback Shabir Rashidi Janne Soikkeli Jerzy Stiasny Elin Sward Lars Vadstrup Johanna Vonkieseritzky |
| author_sort | Teemu Karjalainen |
| collection | DOAJ |
| description | Introduction Triangular fibrocartilage complex (TFCC) tear is often considered to be the cause of ulnar wrist pain. The primary treatment typically involves non-operative methods; however, in cases of persistent symptoms, operative intervention has been proposed as a viable option. Depending on the tear’s morphology, treatment may involve debridement (central or radial tear) or repair (peripheral tear). Efficacy of operative treatment has not been studied in a randomised controlled trial.Methods and analysis This is a prospective, randomised, controlled, blinded multicentre trial, with two randomisation stratums. The first stratum includes central or radial TFCC tears, while the second stratum comprises peripheral TFCC tears. Each stratum consists of two parallel 1:1 arms, comparing the efficacy of (1) debridement of central or radial tear with placebo surgery and (2) repair of peripheral tear with physiotherapy. Participants are recruited from secondary and tertiary referral hospitals in Denmark, Finland and Sweden.Primary outcome is the Patient-Rated Wrist Evaluation (PRWE) at 1 year. Secondary outcomes include subjective and objective outcome measures at 6 months, 1, 2, 5 and 10 years follow-ups.Ethics and dissemination The trial was approved by the Pirkanmaa Hospital District Institutional Review Board in March 2020. All participants will be asked to give a written informed consent. The results of the trial will be disseminated as published articles in peer-reviewed journals.Trial registration number NCT04576169. |
| format | Article |
| id | doaj-art-462c3adb805848e394aab01ce8f90c74 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-462c3adb805848e394aab01ce8f90c742025-08-20T02:36:46ZengBMJ Publishing GroupBMJ Open2044-60552024-12-01141210.1136/bmjopen-2024-086102tREatment of trIaNgular FibrOcaRtilage ComplEx Ruptures (REINFORCER): protocol for randomised, controlled, blinded, efficacy trial of triangular fibrocartilage complex tearsTeemu Karjalainen0Jarkko Jokihaara1Ville M Mattila2Aleksi Reito3Antti Kaivorinne4Toni LuokkalaMikko Petteri Räisänen5Robert Gvozdenovic6Maria Wilcke7Turkka Anttila8Annele Pönkkö9Carsten Lauridsen10Tuukka Tanskanen11Matti JuntunenOlli-Pekka KangasniemiMorten KjaerHeli LähdeniemiPanu NordbackShabir RashidiJanne SoikkeliJerzy StiasnyElin SwardLars VadstrupJohanna VonkieseritzkyDepartment of Surgery, Hospital Nova of Central Finland, Jyvaskyla, FinlandDepartment of Musculoskeletal Diseases, Tampere University Hospital, Tampere, FinlandDepartment of Musculoskeletal Diseases, Tampere University Hospital, Tampere, FinlandDepartment of Musculoskeletal Diseases, Tampere University Hospital, Tampere, FinlandDepartment of Musculoskeletal Diseases, Tampere University Hospital, Tampere, FinlandFaculty of Medicine and Health Technology, Tampere University, Tampere, FinlandDepartment of Hand Surgery, Gentofte Hospital, Hellerup, DenmarkDepartment of Clinical Science and Education, Karolinska Institute, Stockholm, SwedenDepartment of Musculoskeletal and Plastic Surgery, Helsinki University Central Hospital, Helsinki, FinlandDepartment of Hand surgery and Orthopaedics, Oulu University Hospital, Oulu, FinlandDepartment of Orthopaedic Surgery, Sonderjylland Hospital Tønder, Sønderborg, DenmarkDepartment of Orthopedic and Traumatology, TYKS Turku University Hospital, Turku, FinlandIntroduction Triangular fibrocartilage complex (TFCC) tear is often considered to be the cause of ulnar wrist pain. The primary treatment typically involves non-operative methods; however, in cases of persistent symptoms, operative intervention has been proposed as a viable option. Depending on the tear’s morphology, treatment may involve debridement (central or radial tear) or repair (peripheral tear). Efficacy of operative treatment has not been studied in a randomised controlled trial.Methods and analysis This is a prospective, randomised, controlled, blinded multicentre trial, with two randomisation stratums. The first stratum includes central or radial TFCC tears, while the second stratum comprises peripheral TFCC tears. Each stratum consists of two parallel 1:1 arms, comparing the efficacy of (1) debridement of central or radial tear with placebo surgery and (2) repair of peripheral tear with physiotherapy. Participants are recruited from secondary and tertiary referral hospitals in Denmark, Finland and Sweden.Primary outcome is the Patient-Rated Wrist Evaluation (PRWE) at 1 year. Secondary outcomes include subjective and objective outcome measures at 6 months, 1, 2, 5 and 10 years follow-ups.Ethics and dissemination The trial was approved by the Pirkanmaa Hospital District Institutional Review Board in March 2020. All participants will be asked to give a written informed consent. The results of the trial will be disseminated as published articles in peer-reviewed journals.Trial registration number NCT04576169.https://bmjopen.bmj.com/content/14/12/e086102.full |
| spellingShingle | Teemu Karjalainen Jarkko Jokihaara Ville M Mattila Aleksi Reito Antti Kaivorinne Toni Luokkala Mikko Petteri Räisänen Robert Gvozdenovic Maria Wilcke Turkka Anttila Annele Pönkkö Carsten Lauridsen Tuukka Tanskanen Matti Juntunen Olli-Pekka Kangasniemi Morten Kjaer Heli Lähdeniemi Panu Nordback Shabir Rashidi Janne Soikkeli Jerzy Stiasny Elin Sward Lars Vadstrup Johanna Vonkieseritzky tREatment of trIaNgular FibrOcaRtilage ComplEx Ruptures (REINFORCER): protocol for randomised, controlled, blinded, efficacy trial of triangular fibrocartilage complex tears BMJ Open |
| title | tREatment of trIaNgular FibrOcaRtilage ComplEx Ruptures (REINFORCER): protocol for randomised, controlled, blinded, efficacy trial of triangular fibrocartilage complex tears |
| title_full | tREatment of trIaNgular FibrOcaRtilage ComplEx Ruptures (REINFORCER): protocol for randomised, controlled, blinded, efficacy trial of triangular fibrocartilage complex tears |
| title_fullStr | tREatment of trIaNgular FibrOcaRtilage ComplEx Ruptures (REINFORCER): protocol for randomised, controlled, blinded, efficacy trial of triangular fibrocartilage complex tears |
| title_full_unstemmed | tREatment of trIaNgular FibrOcaRtilage ComplEx Ruptures (REINFORCER): protocol for randomised, controlled, blinded, efficacy trial of triangular fibrocartilage complex tears |
| title_short | tREatment of trIaNgular FibrOcaRtilage ComplEx Ruptures (REINFORCER): protocol for randomised, controlled, blinded, efficacy trial of triangular fibrocartilage complex tears |
| title_sort | treatment of triangular fibrocartilage complex ruptures reinforcer protocol for randomised controlled blinded efficacy trial of triangular fibrocartilage complex tears |
| url | https://bmjopen.bmj.com/content/14/12/e086102.full |
| work_keys_str_mv | AT teemukarjalainen treatmentoftriangularfibrocartilagecomplexrupturesreinforcerprotocolforrandomisedcontrolledblindedefficacytrialoftriangularfibrocartilagecomplextears AT jarkkojokihaara treatmentoftriangularfibrocartilagecomplexrupturesreinforcerprotocolforrandomisedcontrolledblindedefficacytrialoftriangularfibrocartilagecomplextears AT villemmattila treatmentoftriangularfibrocartilagecomplexrupturesreinforcerprotocolforrandomisedcontrolledblindedefficacytrialoftriangularfibrocartilagecomplextears AT aleksireito treatmentoftriangularfibrocartilagecomplexrupturesreinforcerprotocolforrandomisedcontrolledblindedefficacytrialoftriangularfibrocartilagecomplextears AT anttikaivorinne treatmentoftriangularfibrocartilagecomplexrupturesreinforcerprotocolforrandomisedcontrolledblindedefficacytrialoftriangularfibrocartilagecomplextears AT toniluokkala treatmentoftriangularfibrocartilagecomplexrupturesreinforcerprotocolforrandomisedcontrolledblindedefficacytrialoftriangularfibrocartilagecomplextears AT mikkopetteriraisanen treatmentoftriangularfibrocartilagecomplexrupturesreinforcerprotocolforrandomisedcontrolledblindedefficacytrialoftriangularfibrocartilagecomplextears AT robertgvozdenovic treatmentoftriangularfibrocartilagecomplexrupturesreinforcerprotocolforrandomisedcontrolledblindedefficacytrialoftriangularfibrocartilagecomplextears AT mariawilcke treatmentoftriangularfibrocartilagecomplexrupturesreinforcerprotocolforrandomisedcontrolledblindedefficacytrialoftriangularfibrocartilagecomplextears AT turkkaanttila treatmentoftriangularfibrocartilagecomplexrupturesreinforcerprotocolforrandomisedcontrolledblindedefficacytrialoftriangularfibrocartilagecomplextears AT anneleponkko treatmentoftriangularfibrocartilagecomplexrupturesreinforcerprotocolforrandomisedcontrolledblindedefficacytrialoftriangularfibrocartilagecomplextears AT carstenlauridsen treatmentoftriangularfibrocartilagecomplexrupturesreinforcerprotocolforrandomisedcontrolledblindedefficacytrialoftriangularfibrocartilagecomplextears AT tuukkatanskanen treatmentoftriangularfibrocartilagecomplexrupturesreinforcerprotocolforrandomisedcontrolledblindedefficacytrialoftriangularfibrocartilagecomplextears AT mattijuntunen treatmentoftriangularfibrocartilagecomplexrupturesreinforcerprotocolforrandomisedcontrolledblindedefficacytrialoftriangularfibrocartilagecomplextears AT ollipekkakangasniemi treatmentoftriangularfibrocartilagecomplexrupturesreinforcerprotocolforrandomisedcontrolledblindedefficacytrialoftriangularfibrocartilagecomplextears AT mortenkjaer treatmentoftriangularfibrocartilagecomplexrupturesreinforcerprotocolforrandomisedcontrolledblindedefficacytrialoftriangularfibrocartilagecomplextears AT helilahdeniemi treatmentoftriangularfibrocartilagecomplexrupturesreinforcerprotocolforrandomisedcontrolledblindedefficacytrialoftriangularfibrocartilagecomplextears AT panunordback treatmentoftriangularfibrocartilagecomplexrupturesreinforcerprotocolforrandomisedcontrolledblindedefficacytrialoftriangularfibrocartilagecomplextears AT shabirrashidi treatmentoftriangularfibrocartilagecomplexrupturesreinforcerprotocolforrandomisedcontrolledblindedefficacytrialoftriangularfibrocartilagecomplextears AT jannesoikkeli treatmentoftriangularfibrocartilagecomplexrupturesreinforcerprotocolforrandomisedcontrolledblindedefficacytrialoftriangularfibrocartilagecomplextears AT jerzystiasny treatmentoftriangularfibrocartilagecomplexrupturesreinforcerprotocolforrandomisedcontrolledblindedefficacytrialoftriangularfibrocartilagecomplextears AT elinsward treatmentoftriangularfibrocartilagecomplexrupturesreinforcerprotocolforrandomisedcontrolledblindedefficacytrialoftriangularfibrocartilagecomplextears AT larsvadstrup treatmentoftriangularfibrocartilagecomplexrupturesreinforcerprotocolforrandomisedcontrolledblindedefficacytrialoftriangularfibrocartilagecomplextears AT johannavonkieseritzky treatmentoftriangularfibrocartilagecomplexrupturesreinforcerprotocolforrandomisedcontrolledblindedefficacytrialoftriangularfibrocartilagecomplextears |