Clinical trial NCT04576169: Trial Comparing Treatment Strategies in Triangular Fibrocartilage Complex Ruptures
Official title: TREatment of Triangular FibrOcaRtilage ComplEx Ruptures (REINFORCER): Protocol for Randomized, Controlled, Blinded, Efficacy Trial of Triangular Fibrocartilage Complex Tears
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Triangular Fibrocartilage Complex Injury
Keywords: Arthroscopy
Surgery
Triangular Fibrocartilage
Randomized Controlled Trial
Placebo
Repair
Wrist
Debridement
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
name: Turku University Hospital
name: Kuopio University Hospital
name: Oulu University Hospital
name: Karolinska Institutet
name: Hospital Sønderjylland
name: Herlev/Gentofte University Hospital of Copenhagen
name: Hospital Nova of Central Finland
First posted: 2020-10-06
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Patient-Rated Wrist Evaluation (PRWE)
timeFrame: 10 year follow-up, primary time point at 1 year
Secondary outcomes:
measure: Quality of life (EQ-5D-3L)
timeFrame: 10 year follow-up
measure: Adverse and serious adverse events
timeFrame: 10 year follow-up
measure: Global improvement
timeFrame: 10 year follow-up
measure: Pain in activity
timeFrame: 10 year follow-up
measure: Grip strength
timeFrame: 2 year follow-up
measure: ROM of forearm and wrist
timeFrame: 2 year follow-up
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Herlev/Gentofte University Hospital of Copenhagen
city: Sønderborg
country: Denmark
facility: Hospital Sønderjylland
city: Jyväskylä
country: Finland
facility: Hospital Nova of Central Finland
state: Keski-Suomi
city: Tampere
country: Finland
facility: Tampere University Hospital
state: Pirkanmaa
city: Oulu
country: Finland
facility: Oulu University Hospital
state: Pohjois-Pohjanmaa
city: Kuopio
country: Finland
facility: Kuopio University Hospital
state: Pohjois-Savo
city: Helsinki
country: Finland
facility: Helsinki University Hospital
state: Uusimaa
city: Turku
country: Finland
facility: Turku University Hospital
state: Varsinais-Suomi
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Antti Kaivorinne, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampere University Hospital
name: Mikko P Räisänen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Nova of Central Finland
name: Teemu Karjalainen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampere University Hospital
name: Aleksi Reito, M.D., Ph.D., Adjunct professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Herlev/Gentofte University Hospital of Copenhagen
name: Robert Gvozdenovic, M.D., Ph. D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Maria Wilcke, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital
name: Turkka Anttila, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Oulu University Hospital
name: Annele Pönkkö, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Sønderjylland
name: Jerzy Stiasny, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Turku University Hospital
name: Tuukka Tanskanen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: