Trial Comparing Treatment Strategies in Triangular Fibrocartilage Complex Ruptures

Study Overview
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Brief Summary
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Trial is a prospective, randomized, controlled, outcome assessor and participant (in other randomization cohort of the trial) blinded, two randomization cohorts, which each has two parallel 1:1 arms, a multinational and -centre trial comparing the efficacy of 1) debridement with placebo surgery and 2) repair with physiotherapy. The primary objective is to compare efficacy of surgery, depending on the type of injury, with either placebo surgery or physiotherapy in 1-year follow-up in two randomization cohorts.

Detailed Description
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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 prospective, randomized, controlled, outcome assessor and participant (in other randomization cohort of the trial) blinded, two randomization cohorts, which each has two parallel 1:1 arms, a multinational and -centre trial comparing the efficacy of 1) debridement with placebo surgery and 2) repair with physiotherapy. 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.

Official Title
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tREatment of Triangular FibrOcaRtilage ComplEx Ruptures (REINFORCER): Protocol for Trial Comparing Debridement Versus Diagnostic Arthroscopy in Central or Radial Tears and Physiotherapy Versus Repair in Ulnar Tears

Conditions
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Triangular Fibrocartilage Complex Injury

Intervention / Treatment
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* Procedure: Arthroscopic Debridement
* Procedure: Placebo surgery
* Procedure: Arthroscopic or Open Repair
* Procedure: Physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ulnar sided wrist pain age more than 18 years suspicion of TFCC tear in clinical examination (MRI optional) ability to fill the Danish, Finnish, Norwegian or Swedish versions of questionnaires symptom duration more than 3 months, and unsuccessful conservative treatment central, radial or ulnar tear explaining the pain in arthroscopy Exclusion Criteria: unstable DRUJ which will be defined as sign of complete instability in clinical examination distal TFCC tear in arthroscopy ulnocarpal or DRUJ arthrosis ulnar variance ≥ +2 mm in x-rays 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Central or Radial Tear: Arthroscopic debridement<br>Arthroscopic debridement | Procedure: Arthroscopic Debridement<br>* A central or radial TFCC tear found during wrist arthroscopy is debrided with a shaver. Portals are closed with sutures or medical tape. The procedure is performed in general or regional anesthesia in operating room. Immediate mobilization of the wrist is allowed after operation. Instructions of home exercise are handed to the patient and patient is instructed to start the exercises two weeks from the operation.<br>|
| Placebo Comparator: Central or Radial Tear: Sham surgery<br>Diagnostic arthroscopy only (placebo surgery). | Procedure: Placebo surgery<br>* Diagnostic arthroscopy only. A central or radial 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. Immediate mobilization of the wrist is allowed after operation. Instructions of home exercise are handed to the patient and patient is instructed to start the exercises two weeks from the operation. The procedure is placebo surgery.<br>|
| Experimental: Ulnar Tear: Arthroscopic or open repair<br>Arthroscopic or open repair | Procedure: Arthroscopic or Open Repair<br>* 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.<br>|
| Active Comparator: Ulnar Tear: Physiotherapy<br>Diagnostic arthroscopy and physiotherapy | Procedure: Physiotherapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Rated Wrist Evaluation (PRWE) | PRWE questionnaire is a validated wrist specific questionnaire consisting of 15-item questionnaire about pain and disability in daily living. PRWE gives a value between 0 (best) and 100 (worst). It is specific wrist instrument with good reliability, validity and responsiveness. In this trial we use minimal important difference (MID) value of 8. It is evaluated pre- and postoperatively. | 10 year follow-up, primary time point at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EQ-5D-3L | Health-related quality of life is measured pre- and postoperatively by EQ-5D-3L questionnaire. It is a generic instrument for assessing quality of life comprising five dimensions and VAS for health level. It is validated and widely used in healthcare research. | 10 year follow-up | 
| Adverse and serious adverse events | We will record all adverse events: tendon, ligament, nerve or arterial injury; fracture, CRPS, infection, chondral lesion and hematoma or any other condition, which can be attributed to the intervention. We will consider events leading to hospitalisation or death as serious adverse events and these will be recorded. | 2 year follow-up | 
| Patient rated global improvement | Global improvement is evaluated pre- and postoperatively by the question: How would you rate the function and pain of your wrist compared to the situation before the treatment? The options are in 7-step Likert scale from (-3) Much worse to (+3) Much better. We will dichotomize the response between 0 (not better or worse) +1 (slightly better). | 10 year follow-up | 
| Pain (VAS) in activity | VAS in use is assessed pre- and postoperatively by VAS scale. The measurement of wrist pain in the affected hand is measured using a 100-mm horizontal line. Pain score is measured between 0 (mm, no pain) and 100 (mm, worst possible) pain. Higher score means worse outcome. | 10 year follow-up | 
| Grip strength | Grip strength is measured pre- and postoperatively with Jamar dynamometer using the handle in 2-position. Elbow is in 90° flexion and attached to chest. The result is reported in kilograms. | 2 year follow-up | 
| Success of blinding with the patient and the outcome assessor | At the two-year control it is asked from the patient and the outcome assessor which group they thought to belong treatment or placebo in central or radial tear randomization cohort. The success of blinding will be reported in per cents. | 1 year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroscopy, Surgery, Triangular Fibrocartilage, Randomized Controlled Trial, Placebo, Repair, Wrist