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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Triangular Fibrocartilage Complex Injury
• Intervention / Treatment: Procedure: Arthroscopic Debridement; Procedure: Placebo surgery; Procedure: Arthroscopic or Open Repair; Procedure: Physiotherapy

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 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.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ville M Mattila, M.D., Ph.D., Professor; Phone Number: +3583311611; Email: ville.mattila@tuni.fi
• Study Contact Backup: Name: Jarkko Jokihaara, M.D., Ph.D., Professor; Phone Number: +3583311611; Email: jarkko.jokihaara@tuni.fi

Study Locations

• Denmark
  • Copenhagen, Denmark, 2900
    • Not yet recruiting
    • Copenhagen University Hospital Gentofte
    • Contact: Robert Gvozdenovic, M.D.; Phone Number: +45 38 67 38 67; Email: Robert.Gvozdenovic@regionh.dk
• Finland
  • Keski-Suomi
    • Jyväskylä, Keski-Suomi, Finland, 40620
      • Recruiting
      • Central Finland Central Hospital
      • Contact: Teemu Karjalainen, M.D., Ph.D.; Phone Number: +358142691811; Email: teemu.karjalainen@ksshp.fi
      • Contact: Toni Luokkala, M.D.; Phone Number: +358142691811; Email: toni.luokkala@ksshp.fi
  • Pirkanmaa
    • Tampere, Pirkanmaa, Finland, 33521
      • Recruiting
      • Tampere university Hospital
      • Contact: Antti Kaivorinne, M.D.; Phone Number: +3583311611; Email: antti.kaivorinne@pshp.fi
      • Contact: Margit C Karelson, M.D.; Phone Number: +3583311611; Email: margit.karelson@pshp.fi
  • Pohjois-Pohjanmaa
    • Oulu, Pohjois-Pohjanmaa, Finland, 90220
      • Not yet recruiting
      • Oulu University Hospital
      • Contact: Johannes Kuorilehto, M.D.; Phone Number: +35883152011; Email: johannes.kuorilehto@psshp.fi
  • Pohjois-Savo
    • Kuopio, Pohjois-Savo, Finland, 70029
      • Recruiting
      • Kuopio University Hospital
      • Contact: Matti Juntunen, M.D.; Phone Number: +35817173311; Email: matti.juntunen@kuh.fi
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00029
      • Not yet recruiting
      • Helsinki University Hospital
      • Contact: Panu Nordback, M.D.; Phone Number: +35894711; Email: panu.nordback@hus.fi
      • Contact: Jorma Ryhänen, M.D., Ph.D., Adjunct prof.; Phone Number: +35894711; Email: jorma.ryhanen@hus.fi
  • Varsinais-Suomi
    • Turku, Varsinais-Suomi, Finland, 20521
      • Not yet recruiting
      • Turku University Hospital
      • Contact: Markus Pääkkönen, M.D., Ph.D., Adjunct prof.; Phone Number: +35823130000; Email: markus.paakkonen@tyks.fi
      • Contact: Hanna-Stiina Taskinen, M.D., Ph.D.; Phone Number: +35823130000; Email: hannastiina.taskinen@tyks.fi
• Norway
  • Grålum, Norway, 1714
    • Not yet recruiting
    • Østfold Hospital Trust
    • Contact: Jan-Ragnar Haugstvedt, M.D., Ph.D.; Phone Number: +47 69 86 00 00; Email: Jan-Ragnar.Haugstvedt@so-hf.no
• Sweden
  • Stockholm, Sweden, 171 76
    • Not yet recruiting
    • Karolinska University Hospital
    • Contact: Maria Wilcke, M.D., Ph.D.; Phone Number: +46 8 517 700 00; Email: maria.wilcke@sll.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Central or Radial Tear: Arthroscopic debridement; Arthroscopic debridement	Procedure: Arthroscopic Debridement; 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.
Placebo Comparator: Central or Radial Tear: Sham surgery; Diagnostic arthroscopy only (placebo surgery).	Procedure: Placebo surgery; 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.
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)	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

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Collaborators: Turku University Hospital; Helsinki University Central Hospital; Oulu University Hospital; Kuopio University Hospital; Central Finland Central Hospital
• Investigators: Principal Investigator: Mikko P Räisänen, M.D., Tampere university Hospital; Principal Investigator: Antti Kaivorinne, M.D., Tampere university Hospital; Principal Investigator: Teemu Karjalainen, M.D., Ph.D., Central Finland Central Hospital; Principal Investigator: Aleksi Reito, M.D., Ph.D., Adjunct professor, Tampere university Hospital; Principal Investigator: Robert Gvozdenovic, M.D., Copenhagen University hospital, Gentofte; Principal Investigator: Jan-Ragnar Haugstvedt, M.D., Ph.D., Ostfold Hospital Trust; Principal Investigator: Maria Wilcke, M.D., Ph.D., Karolinska University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2020
• Primary Completion (Anticipated): March 31, 2027
• Study Completion (Anticipated): March 31, 2027

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 (Actual): August 31, 2021
• Last Update Submitted That Met QC Criteria: August 25, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Surgery; Randomized Controlled Trial; Placebo; Arthroscopy; Repair; Wrist; Triangular Fibrocartilage
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• 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; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No