Kaivorinne Antti, Räisänen Mikko Petteri, Karjalainen Teemu, Jokihaara Jarkko, Gvozdenovic Robert, Wilcke Maria, Reito Aleksi, Anttila Turkka, Pönkkö Annele, Lauridsen Carsten, Tanskanen Tuukka, Mattila Ville M
Department of Musculoskeletal Diseases, Tampere University Hospital, Tampere, Finland.
Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.
BMJ Open. 2024 Dec 11;14(12):e086102. doi: 10.1136/bmjopen-2024-086102.
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.
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.
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.
NCT04576169.
三角纤维软骨复合体（TFCC）撕裂常被认为是尺侧腕部疼痛的原因。主要治疗通常采用非手术方法；然而，对于症状持续的病例，手术干预已被提议作为一种可行的选择。根据撕裂的形态，治疗可能包括清创术（中央或桡侧撕裂）或修复术（周边撕裂）。手术治疗的疗效尚未在随机对照试验中进行研究。
这是一项前瞻性、随机、对照、双盲多中心试验，有两个随机分层。第一层包括中央或桡侧TFCC撕裂，而第二层包括周边TFCC撕裂。每个分层由两个平行的1:1组组成，比较（1）中央或桡侧撕裂清创术与安慰剂手术的疗效，以及（2）周边撕裂修复术与物理治疗的疗效。参与者从丹麦、芬兰和瑞典的二级和三级转诊医院招募。主要结局是1年时的患者腕关节评估评分（PRWE）。次要结局包括6个月、1年、2年、5年和10年随访时的主观和客观结局指标。
该试验于2020年3月获得皮尔卡马医院区机构审查委员会的批准。所有参与者将被要求签署书面知情同意书。试验结果将以发表文章的形式在同行评审期刊上传播。
NCT04576169。
