Trial Comparing Treatment Strategies in Triangular Fibrocartilage Complex Ruptures

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.

Conditions

• Triangular Fibrocartilage Complex Injury

Interventions

PROCEDURE

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.

PROCEDURE

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.

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

• Helsinki University Central Hospital

  collaborator OTHER

• Turku University Hospital

  collaborator OTHER_GOV

• Kuopio University Hospital

  collaborator OTHER

• Oulu University Hospital

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• Hospital Sønderjylland

  collaborator UNKNOWN

• Copenhagen University Hospital at Herlev

  collaborator OTHER

• Hospital Nova of Central Finland

  collaborator UNKNOWN

• Tampere University Hospital

  lead OTHER

Principal Investigators

• Antti Kaivorinne, M.D. · Tampere University Hospital

• Mikko P Räisänen, M.D. · Tampere University Hospital

• Teemu Karjalainen, M.D., Ph.D. · Hospital Nova of Central Finland

• Aleksi Reito, M.D., Ph.D., Adjunct professor · Tampere University Hospital

• Robert Gvozdenovic, M.D., Ph. D. · Copenhagen University Hospital at Herlev

• Maria Wilcke, M.D., Ph.D. · Karolinska Institutet

• Turkka Anttila, M.D. · Helsinki University Central Hospital

• Annele Pönkkö, M.D. · Oulu University Hospital

• Jerzy Stiasny, M.D. · Hospital Sønderjylland

• Tuukka Tanskanen, M.D. · Turku University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-27

Primary Completion

2028-03-31

Completion

2035-03-31

Countries

• Denmark
• Finland
• Sweden

Study Locations