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

• ClinicalTrials.gov Identifier: NCT04576169
• Recruitment Status: Recruiting
• First Posted: October 6, 2020
• Last Update Posted: August 31, 2021
• Sponsor: Tampere University Hospital
• Collaborators: Central Finland Central Hospital; Helsinki University Central Hospital; Turku University Hospital; Kuopio University Hospital; Oulu University Hospital
• Information provided by (Responsible Party): Jarkko Jokihaara, Tampere University Hospital

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Triangular Fibrocartilage Complex Injury	Procedure: Arthroscopic Debridement; Procedure: Placebo surgery; Procedure: Arthroscopic or Open Repair; Procedure: Physiotherapy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Lead investigators (LI), Coordinating research assistant (CRA), operating theatre staff and research assistants (RA) cannot be blinded to the allocation. Outcome assessors are blinded, and they do not participate in the care at any other point of the study than control visits. In the debridement versus placebo surgery randomization cohort all other hospital personnel and participant will be blinded. In repair of the TFCC (1B) versus physiotherapy randomization cohort we will not attempt blinding as the postoperative treatment is different; long immobilization of the physiotherapy group, and on the other hand, early mobilisation of the repair group may have negative impact on the outcomes.
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: October 27, 2020
• Estimated Primary Completion Date: March 31, 2027
• Estimated Study Completion Date: March 31, 2027

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. EQ-5D-3L [ Time Frame: 10 year follow-up ]
   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.
2. Adverse and serious adverse events [ Time Frame: 2 year follow-up ]
   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.
3. Patient rated global improvement [ Time Frame: 10 year follow-up ]
   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).
4. Pain (VAS) in activity [ Time Frame: 10 year follow-up ]
   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.
5. Grip strength [ Time Frame: 2 year follow-up ]
   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.
6. Success of blinding with the patient and the outcome assessor [ Time Frame: 1 year follow-up ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Ville M Mattila, M.D., Ph.D., Professor; +3583311611; ville.mattila@tuni.fi

Contact: Jarkko Jokihaara, M.D., Ph.D., Professor; +3583311611; jarkko.jokihaara@tuni.fi

Locations

Denmark

Copenhagen University Hospital Gentofte; Not yet recruiting

Copenhagen, Denmark, 2900

Contact: Robert Gvozdenovic, M.D. +45 38 67 38 67 Robert.Gvozdenovic@regionh.dk

Finland

Central Finland Central Hospital; Recruiting

Jyväskylä, Keski-Suomi, Finland, 40620

Contact: Teemu Karjalainen, M.D., Ph.D. +358142691811 teemu.karjalainen@ksshp.fi

Contact: Toni Luokkala, M.D. +358142691811 toni.luokkala@ksshp.fi

Tampere University Hospital; Recruiting

Tampere, Pirkanmaa, Finland, 33521

Contact: Antti Kaivorinne, M.D. +3583311611 antti.kaivorinne@pshp.fi

Contact: Margit C Karelson, M.D. +3583311611 margit.karelson@pshp.fi

Oulu University Hospital; Not yet recruiting

Oulu, Pohjois-Pohjanmaa, Finland, 90220

Contact: Johannes Kuorilehto, M.D. +35883152011 johannes.kuorilehto@psshp.fi

Kuopio University Hospital; Recruiting

Kuopio, Pohjois-Savo, Finland, 70029

Contact: Matti Juntunen, M.D. +35817173311 matti.juntunen@kuh.fi

Helsinki University Hospital; Not yet recruiting

Helsinki, Uusimaa, Finland, 00029

Contact: Panu Nordback, M.D. +35894711 panu.nordback@hus.fi

Contact: Jorma Ryhänen, M.D., Ph.D., Adjunct prof. +35894711 jorma.ryhanen@hus.fi

Turku University Hospital; Not yet recruiting

Turku, Varsinais-Suomi, Finland, 20521

Contact: Markus Pääkkönen, M.D., Ph.D., Adjunct prof. +35823130000 markus.paakkonen@tyks.fi

Contact: Hanna-Stiina Taskinen, M.D., Ph.D. +35823130000 hannastiina.taskinen@tyks.fi

Norway

Østfold Hospital Trust; Not yet recruiting

Grålum, Norway, 1714

Contact: Jan-Ragnar Haugstvedt, M.D., Ph.D. +47 69 86 00 00 Jan-Ragnar.Haugstvedt@so-hf.no

Sweden

Karolinska University Hospital; Not yet recruiting

Stockholm, Sweden, 171 76

Contact: Maria Wilcke, M.D., Ph.D. +46 8 517 700 00 maria.wilcke@sll.se

Sponsors and Collaborators

Tampere University Hospital

Central Finland Central Hospital

Helsinki University Central Hospital

Turku University Hospital

Kuopio University Hospital

Oulu University Hospital

Investigators

• Principal Investigator: Antti Kaivorinne, M.D.; Tampere University Hospital
• Principal Investigator: Mikko P Räisänen, 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

More Information

• Responsible Party: Jarkko Jokihaara, Associate professor of hand surgery, Tampere University Hospital
• ClinicalTrials.gov Identifier: NCT04576169
• Other Study ID Numbers: Tampere University Hospital
• First Posted: October 6, 2020
• Last Update Posted: August 31, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: All the IPD will be shared with other researchers by request.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code
• Time Frame: Data will be available after the publication and it will be available for 15 years.
• Access Criteria: By request.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jarkko Jokihaara, Tampere University Hospital:

Arthroscopy; Surgery; Triangular Fibrocartilage; Randomized Controlled Trial; Placebo; Repair; Wrist

Additional relevant MeSH terms:

Rupture; Wounds and Injuries