Trial Comparing Treatment Strategies in Triangular Fibrocartilage Complex Ruptures

Официальное название

TREatment of Triangular FibrOcaRtilage ComplEx Ruptures (REINFORCER): Protocol for Randomized, Controlled, Blinded, Efficacy Trial of Triangular Fibrocartilage Complex Tears

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.
• Процедура 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 ope
• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Patient-Rated Wrist Evaluation (PRWE) [Срок оценки: 10 year follow-up, primary time point at 1 year]

Вторичные конечные точки (6)

• Quality of life (EQ-5D-3L) [Срок оценки: 10 year follow-up]
• Adverse and serious adverse events [Срок оценки: 10 year follow-up]
• Global improvement [Срок оценки: 10 year follow-up]
• Pain in activity [Срок оценки: 10 year follow-up]
• Grip strength [Срок оценки: 2 year follow-up]
• ROM of forearm and wrist [Срок оценки: 2 year follow-up]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Финляндия · 6 центров

• Hospital Nova of Central Finland — Jyväskylä
• Oulu University Hospital — Oulu
• Kuopio University Hospital — Kuopio
• Tampere University Hospital — Tampere
• Turku University Hospital — Turku
• Helsinki University Hospital — Helsinki

Дания · 2 центра

• Herlev/Gentofte University Hospital of Copenhagen — Copenhagen
• Hospital Sønderjylland — Sønderborg

Швеция · 1 центр

• Karolinska University Hospital — Stockholm

Публикации

• 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/ PMID 39663172

Идентификаторы

NCT: NCT04576169 · Tampere University Hospital

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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