REINFORCER: Trial Comparing Treatment Strategies in Triangular Fibrocartilage Complex Ruptures

Sponsor

Tampere University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04576169

Collaborator

Central Finland Central Hospital (Other), Helsinki University Central Hospital (Other), Turku University Hospital (Other), Kuopio University Hospital (Other), Oulu University Hospital (Other)

160

Enrollment

Locations

Arms

77.1

Anticipated Duration (Months)

17.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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	N/A

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

Anticipated 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 :

Oct 27, 2020

Anticipated Primary Completion Date :

Mar 31, 2027

Anticipated Study Completion Date :

Mar 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

Patient-Rated Wrist Evaluation (PRWE) [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

EQ-5D-3L [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.
Adverse and serious adverse events [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.
Patient rated global improvement [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).
Pain (VAS) in activity [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.
Grip strength [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.
Success of blinding with the patient and the outcome assessor [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

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Copenhagen University Hospital Gentofte	Copenhagen		Denmark	2900
2	Central Finland Central Hospital	Jyväskylä	Keski-Suomi	Finland	40620
3	Tampere University Hospital	Tampere	Pirkanmaa	Finland	33521
4	Oulu University Hospital	Oulu	Pohjois-Pohjanmaa	Finland	90220
5	Kuopio University Hospital	Kuopio	Pohjois-Savo	Finland	70029
6	Helsinki University Hospital	Helsinki	Uusimaa	Finland	00029
7	Turku University Hospital	Turku	Varsinais-Suomi	Finland	20521
8	Østfold Hospital Trust	Grålum		Norway	1714
9	Karolinska University Hospital	Stockholm		Sweden	171 76

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