Triangular Fibrocartilage Complex InjuryREINFORCERNCT04576169
Trial Comparing Treatment Strategies in Triangular Fibrocartilage Complex Ruptures
A study testing Arthroscopic Debridement, Arthroscopic or Open Repair and Physiotherapy in people with Triangular Fibrocartilage Complex Injury, run by Tampere University Hospital at 9 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Triangular Fibrocartilage Complex Injury
- What is being tested?
- Arthroscopic Debridement, Arthroscopic or Open Repair and Physiotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 27 Oct 2020to 31 Mar 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Lunotriquetral instability diagnosed in arthroscopy
- ECU instability
- Massive tear and degenerated edges or frayed tear which fails suture (Atzei class 4A-4B)
Trial locations and contacts
9 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 3 countries
Finland6 sites, 6 recruiting
- Recruiting
Helsinki University Hospital
Helsinki, Uusimaa, 00029
Turkka Anttila, M.D., +35894711, turkka.anttila@hus.fi
Panu Nordback, M.D., Ph.D., Adjunct prof., +35894711, panu.nordback@hus.fi
- Recruiting
Hospital Nova of Central Finland
Jyväskylä, Central Finland, 40620
Teemu Karjalainen, M.D., Ph.D., +358142691811, teemu.karjalainen@ksshp.fi
Toni Luokkala, M.D., +358142691811, toni.luokkala@ksshp.fi
- Recruiting
Kuopio University Hospital
Kuopio, Northern Savonia, 70029
Mikko P Räisänen, M.D., +35817173311, mikko.raisanen@pshyvinvointialue.fi
Matti Juntunen, M.D., +35817173311, matti.juntunen@pshyvinvointialue.fi
- Recruiting
Oulu University Hospital
Oulu, North Ostrobothnia, 90220
Annele Pönkkö, M.D., +35883152011, annele.ponkko@pohde.fi
Janne Soikkeli, M.D., +35883152011, janne.soikkeli@pohde.fi
- Recruiting
Tampere University Hospital
Tampere, Pirkanmaa, 33521
Antti Kaivorinne, M.D., +3583311611, antti.kaivorinne@pirha.fi
Patrick Luukinen, M.D., +3583311611, patrick.luukinen@pirha.fi
- Recruiting
Turku University Hospital
Turku, Southwest Finland, 20521
Tuukka Tanskanen, M.D, +35823130000, tuukka.tanskanen@tyks.fi
Heli Lähdeniemi, M.D., +35823130000, heli.lahdeniemi@tyks.fi
Denmark2 sites, 2 recruiting
- Recruiting
Herlev/Gentofte University Hospital of Copenhagen
Copenhagen, 2900
Robert Gvozdenovic, M.D., +45 38 67 38 67, Robert.Gvozdenovic@regionh.dk
- Recruiting
Hospital Sønderjylland
Sønderborg
Jerzy Stiasny, M.D.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, 171 76
Maria Wilcke, M.D., Ph.D., +46 8 517 700 00, maria.wilcke@sll.se
About this study
Official title: 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.
Read the 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.
- Conditions
- Triangular Fibrocartilage Complex Injury
- Being tested
- Arthroscopic Debridement, Placebo surgery, Arthroscopic or Open Repair, Physiotherapy
- Keywords
- Arthroscopy, Surgery, Triangular Fibrocartilage, Randomized Controlled Trial, Placebo, Repair, Wrist, Debridement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic DebridementProcedure or surgery
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 surgeryProcedure or 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.
Arthroscopic or Open RepairProcedure or surgery
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.
PhysiotherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Central or Radial Tear: Arthroscopic debridement | Experimental | Arthroscopic debridement Receives: Procedure: Arthroscopic Debridement |
| Central or Radial Tear: Sham surgery | Placebo comparator | Diagnostic arthroscopy only (placebo surgery). Receives: Procedure: Placebo surgery |
| Ulnar Tear: Arthroscopic or open repair | Experimental | Arthroscopic or open repair Receives: Procedure: Arthroscopic or Open Repair |
| Ulnar Tear: Physiotherapy | Active comparator | Diagnostic arthroscopy and physiotherapy Receives: Procedure: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Rated Wrist Evaluation (PRWE)
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.
Measured: 10 year follow-up, primary time point at 1 year
Secondary outcomes (6)
Quality of life (EQ-5D-3L)
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.
Measured: 10 year follow-up
Adverse and serious adverse events
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.
Measured: 10 year follow-up
Global improvement
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.
Measured: 10 year follow-up
Pain in activity
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.
Measured: 10 year follow-up
Grip strength
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.
Measured: 2 year follow-up
ROM of forearm and wrist
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.
Measured: 2 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start27 Oct 2020
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Triangular Fibrocartilage Complex InjuryStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, Turku University Hospital, Kuopio University Hospital, Oulu University Hospital, Karolinska Institutet, Hospital Sønderjylland, Copenhagen University Hospital at Herlev, Hospital Nova, Central Finland
- Responsible party
- Principal investigator, Jarkko Jokihaara, Tampere University Hospital
- Investigators
- Antti Kaivorinne, M.D., Principal investigator, Tampere University HospitalMikko P Räisänen, M.D., Principal investigator, Tampere University HospitalTeemu Karjalainen, M.D., Ph.D., Principal investigator, Hospital Nova, Central FinlandAleksi Reito, M.D., Ph.D., Adjunct professor, Principal investigator, Tampere University HospitalRobert Gvozdenovic, M.D., Ph. D., Principal investigator, Copenhagen University Hospital at HerlevMaria Wilcke, M.D., Ph.D., Principal investigator, Karolinska InstitutetTurkka Anttila, M.D., Principal investigator, Helsinki University Central HospitalAnnele Pönkkö, M.D., Principal investigator, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576169
- Sponsor's protocol ID
- Tampere University Hospital
- Acronym
- REINFORCER
- Status last verified
- Oct 2024
- First submitted
- 29 Sep 2020
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the IPD will be shared with other researchers by request.
Publications
Kaivorinne A, Raisanen MP, Karjalainen T, Jokihaara J, Gvozdenovic R, Wilcke M, Reito A, Anttila T, Ponkko A, Lauridsen C, Tanskanen T, Mattila VM; REINFORCER investigators. tREatment of trIaNgular FibrOcaRtilage ComplEx Ruptures (REINFORCER): protocol for randomised, controlled, blinded, efficacy trial of triangular fibrocartilage complex tears. BMJ Open. 2024 Dec 11;14(12):e086102. doi: 10.1136/bmjopen-2024-086102.
PubMed 39663172
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TREatment of Triangular FibrOcaRtilage ComplEx Ruptures (REINFORCER): Protocol for Randomized, Controlled, Blinded, Efficacy Trial of Triangular Fibrocartilage Complex Tears
- ClinicalTrials.gov ID
- NCT04576169
- Acronym / sponsor ID
- REINFORCER / Tampere University Hospital
- Conditions
- Triangular Fibrocartilage Complex Injury
- Keywords
- Arthroscopy, Surgery, Triangular Fibrocartilage, Randomized Controlled Trial, Placebo, Repair, Wrist, Debridement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, Turku University Hospital, Kuopio University Hospital, Oulu University Hospital, Karolinska Institutet, Hospital Sønderjylland, Copenhagen University Hospital at Herlev, Hospital Nova, Central Finland
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2035 (estimated)
- First posted
- 6 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Central or Radial Tear: Arthroscopic debridement | Experimental | Procedure: Arthroscopic DebridementArthroscopic debridement |
| Central or Radial Tear: Sham surgery | Placebo comparator | Procedure: Placebo surgeryDiagnostic arthroscopy only (placebo surgery). |
| Ulnar Tear: Arthroscopic or open repair | Experimental | Procedure: Arthroscopic or Open RepairArthroscopic or open repair |
| Ulnar Tear: Physiotherapy | Active comparator | Procedure: PhysiotherapyDiagnostic arthroscopy and physiotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopic DebridementWrist 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. | Procedure or surgery | Central or Radial Tear: Arthroscopic debridement |
| Placebo surgeryDiagnostic 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. | Procedure or surgery | Central or Radial Tear: Sham surgery |
| Arthroscopic or Open RepairAn 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. | Procedure or surgery | Ulnar Tear: Arthroscopic or open repair |
| PhysiotherapyAn 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. | Procedure or surgery | Ulnar Tear: Physiotherapy |
Primary outcome
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.
6 secondary outcomes
Quality of life (EQ-5D-3L)
Time frame: 10 year follow-up
Adverse and serious adverse events
Time frame: 10 year follow-up
Global improvement
Time frame: 10 year follow-up
Pain in activity
Time frame: 10 year follow-up
Grip strength
Time frame: 2 year follow-up
ROM of forearm and wrist
Time frame: 2 year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Derived from this study: PubMed 39663172Kaivorinne A, Raisanen MP, Karjalainen T, Jokihaara J, Gvozdenovic R, Wilcke M, Reito A, Anttila T, Ponkko A, Lauridsen C, Tanskanen T, Mattila VM; REINFORCER investigators. tREatment of trIaNgular FibrOcaRtilage ComplEx Ruptures (REINFORCER): protocol for randomised, controlled, blinded, efficacy trial of triangular fibrocartilage complex tears. BMJ Open. 2024 Dec 11;14(12):e086102. doi: 10.1136/bmjopen-2024-086102.
- Individual participant dataSharing planned: Yes. All the IPD will be shared with other researchers by request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antti Kaivorinne, M.D. principal investigator
Tampere University Hospital
Mikko P Räisänen, M.D. principal investigator
Tampere University Hospital
Teemu Karjalainen, M.D., Ph.D. principal investigator
Hospital Nova, Central Finland
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic Debridement, Arthroscopic or Open Repair and Physiotherapy in people with Triangular Fibrocartilage Complex Injury, run by Tampere University Hospital at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Finland, Denmark, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ville M Mattila, M.D., Ph.D., Professor (+3583311611, ville.mattila@tuni.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Rated Wrist Evaluation (PRWE) (time frame: 10 year follow-up, primary time point at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04576169, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.