Trial Comparing Treatment Strategies in Triangular Fibrocartilage Complex Ruptures
- Conditions
- Triangular Fibrocartilage Complex Injury
- Interventions
- Procedure: Arthroscopic DebridementProcedure: Placebo surgeryProcedure: Arthroscopic or Open RepairProcedure: Physiotherapy
- Registration Number
- NCT04576169
- Lead Sponsor
- Tampere University Hospital
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 204
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Central or Radial Tear: Arthroscopic debridement Arthroscopic Debridement Arthroscopic debridement Central or Radial Tear: Sham surgery Placebo surgery Diagnostic arthroscopy only (placebo surgery). Ulnar Tear: Arthroscopic or open repair Arthroscopic or Open Repair Arthroscopic or open repair Ulnar Tear: Physiotherapy Physiotherapy Diagnostic arthroscopy and physiotherapy
- Primary Outcome Measures
Name Time Method Patient-Rated Wrist Evaluation (PRWE) 10 year follow-up, primary time point at 1 year The PRWE questionnaire is a wrist-specific instrument comprising a 15-item questionnaire assessing pain and disability in daily living. PRWE provides a score ranging from 0 (best) to 100 (worst). This wrist-specific tool demonstrates good reliability, validity, and responsiveness. Translation and validation have been conducted for Danish, Finnish, and Swedish languages. In interpreting the results, we will employ the Minimally Important Difference (MID) value of 14. PRWE as secondary outcome will be measured at all the other time points (6 months, 2, 5 and 10 years) than primary outcome.
- Secondary Outcome Measures
Name Time Method Quality of life (EQ-5D-3L) 10 year follow-up The EQ-5D-3L is a widely employed, health-related quality of life instrument comprising five dimensions and a visual VAS for health level. The five dimensions assessed by EQ-5D-3L include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each dimension, patients rate their current state on each dimension using a 3-point scale, and the VAS scale ranges from 0 (worst) to 100 (best). Utility or preference weights, applied with an aggregation formula, yield a single index number used to evaluate overall health-related quality of life. It has been proven to be a reliable and validated tool and it is widely used in healthcare research. The EQ-5D-3L has demonstrated good responsiveness in upper extremity conditions, such as distal radius fractures, its responsiveness in hand surgery has not been measured previously. The MID for the index is 0.085 and for the VAS 6.41. Translation and validation for Danish, Finnish, and Swedish languages have been conducted.
Adverse and serious adverse events 10 year follow-up All wrist-related adverse events will be documented: ligament, nerve, tendon, or vascular injury; fracture; CRPS; infection; chondral lesion; hematoma; or any other condition that can be attributed to the intervention. Participants are instructed to promptly notify the outpatient clinic at their center if they detect a potential adverse event. Additionally, adverse events will be assessed during each follow-up visit. Any events resulting in hospitalization or death will be classified as SAE.
Global improvement 10 year follow-up Patient-rated global improvement will be assessed using the question: "How would you rate the function and pain of your wrist compared to the situation before the treatment?" Participants will provide responses on a 7-step Likert scale, ranging from "Much worse" to "Much better.". This global rating of the treatment effect offers a subjective evaluation of the participant's perception of the treatment's impact on their wrist condition. It enables participants to offer feedback on their overall experience and evaluate the practical significance of the treatment's effect on their wrist. The Likert scale, a simple and effective tool for assessing participant-evaluated global ratings, is widely used in clinical research.
Pain in activity 10 year follow-up Pain during activity will be evaluated using the VAS, a validated and reliable tool for pain assessment. Widely employed in pain assessments, the VAS scale ranges from 0 to 100 mm, with higher values indicating more severe pain. The MID for VAS-pain is reported to fall between 16-19 mm.
Grip strength 2 year follow-up Grip strength will be assessed using the Jamar dynamometer, known for its good within-instrument reliability (Spearman Rho correlation coefficient test 0.82). The strength measurement will be performed with the handle in two positions: with the elbow in 90° flexion and the arm in adduction. Results will be reported in kilograms. The MID of grip strength is reported to be 5.5 kg.
ROM of forearm and wrist 2 year follow-up Passive ROM of the forearm and wrist are commonly employed as outcomes in studies addressing the treatment of wrist pathologies. Prosupination, recorded as forearm ROM, will be measured with the elbow at 90° flexion. Wrist ROM measurements will include extension, flexion, ulnar deviation, and radial deviation. MID of forearm and wrist ROM have not been determined.
Trial Locations
- Locations (9)
Herlev/Gentofte University Hospital of Copenhagen
🇩🇰Copenhagen, Denmark
Hospital Sønderjylland
🇩🇰Sønderborg, Denmark
Hospital Nova of Central Finland
🇫🇮Jyväskylä, Keski-Suomi, Finland
Tampere University Hospital
🇫🇮Tampere, Pirkanmaa, Finland
Oulu University Hospital
🇫🇮Oulu, Pohjois-Pohjanmaa, Finland
Kuopio University Hospital
🇫🇮Kuopio, Pohjois-Savo, Finland
Helsinki University Hospital
🇫🇮Helsinki, Uusimaa, Finland
Turku University Hospital
🇫🇮Turku, Varsinais-Suomi, Finland
Karolinska University Hospital
🇸🇪Stockholm, Sweden