Trial Comparing Treatment Strategies in Triangular Fibrocartilage Complex Ruptures (REINFORCER)

October 7, 2024 updated by: Jarkko Jokihaara, Tampere University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2900
        • Recruiting
        • Herlev/Gentofte University Hospital of Copenhagen
        • Contact:
      • Sønderborg, Denmark
        • Recruiting
        • Hospital Sønderjylland
        • Contact:
          • Jerzy Stiasny, M.D.
  • Finland
    • Keski-Suomi
      • Jyväskylä, Keski-Suomi, Finland, 40620
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33521
    • Pohjois-Pohjanmaa
      • Oulu, Pohjois-Pohjanmaa, Finland, 90220
        • Recruiting
        • Oulu University Hospital
        • Contact:
        • Contact:
        • Contact:
          • Matti-Aleksi Mosorin, M.D.
    • Pohjois-Savo
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00029
        • Recruiting
        • Helsinki University Hospital
        • Contact:
        • Contact:
    • Varsinais-Suomi
      • Turku, Varsinais-Suomi, Finland, 20521
  • Sweden
      • Stockholm, Sweden, 171 76
        • Recruiting
        • Karolinska University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Central or Radial Tear: Arthroscopic debridement
Arthroscopic debridement
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.
Placebo Comparator: Central or Radial Tear: Sham surgery
Diagnostic arthroscopy only (placebo surgery).
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.
Experimental: Ulnar Tear: Arthroscopic or open repair
Arthroscopic or open repair
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.
Active Comparator: Ulnar Tear: Physiotherapy
Diagnostic arthroscopy and physiotherapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-Rated Wrist Evaluation (PRWE)
Time Frame: 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.
10 year follow-up, primary time point at 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life (EQ-5D-3L)
Time Frame: 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.
10 year follow-up
Adverse and serious adverse events
Time Frame: 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.
10 year follow-up
Global improvement
Time Frame: 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.
10 year follow-up
Pain in activity
Time Frame: 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.
10 year follow-up
Grip strength
Time Frame: 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.
2 year follow-up
ROM of forearm and wrist
Time Frame: 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.
2 year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Collaborators

Karolinska Institutet
Turku University Hospital
Helsinki University Central Hospital
Oulu University Hospital
Kuopio University Hospital
Hospital Nova of Central Finland
Hospital Sønderjylland
Herlev/Gentofte University Hospital of Copenhagen

Investigators

  • Principal Investigator: Mikko P Räisänen, M.D., Tampere University Hospital
  • Principal Investigator: Antti Kaivorinne, M.D., Tampere University Hospital
  • Principal Investigator: Aleksi Reito, M.D., Ph.D., Adjunct professor, Tampere University Hospital
  • Principal Investigator: Teemu Karjalainen, M.D., Ph.D., Hospital Nova of Central Finland
  • Principal Investigator: Robert Gvozdenovic, M.D., Ph. D., Herlev/Gentofte University Hospital of Copenhagen
  • Principal Investigator: Maria Wilcke, M.D., Ph.D., Karolinska Institutet
  • Principal Investigator: Turkka Anttila, M.D., Helsinki University Central Hospital
  • Principal Investigator: Annele Pönkkö, M.D., Oulu University Hospital
  • Principal Investigator: Jerzy Stiasny, M.D., Hospital Sønderjylland
  • Principal Investigator: Tuukka Tanskanen, M.D., Turku University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2020

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2035

Study Registration Dates

First Submitted

September 29, 2020

First Submitted That Met QC Criteria

September 29, 2020

First Posted (Actual)

October 6, 2020

Study Record Updates

Last Update Posted (Estimated)

October 9, 2024

Last Update Submitted That Met QC Criteria

October 7, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tampere University Hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All the IPD will be shared with other researchers by request.

IPD Sharing Time Frame

Data will be available after the publication and it will be available for 15 years.

IPD Sharing Access Criteria

By request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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