Proximal Row Carpectomy vs Four-corner Fusion for Osteoarthritis of the Wrist
NCT ID: NCT04260165
Last Updated: 2021-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
84 participants
INTERVENTIONAL
2020-10-01
2034-12-31
Brief Summary
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Patients with radiologically and clinically confirmed OA are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo either PRC or FCA. The study will be patient and assessor blinded.
Baseline data is collected preoperatively and is followed by a follow-up visits at 2 and 6 weeks, 3, 6, 12 months, and 5, 10 years after the intervention. Unveiling of the allocation is at 12 months post-intervention.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Proximal Row Carpectomy
Proximal Row Carpectomy
Excision of the proximal carpal row - the scaphoid, lunate and triquetrum
Four-corner fusion
Four-corner fusion
Scaphoid excision and four-corner fusion with cannulated headless compression screws/dorsal plate
Interventions
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Proximal Row Carpectomy
Excision of the proximal carpal row - the scaphoid, lunate and triquetrum
Four-corner fusion
Scaphoid excision and four-corner fusion with cannulated headless compression screws/dorsal plate
Eligibility Criteria
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Inclusion Criteria
* Age 18 - 75
* Symptom duration \> 3 months
* American Society of Anaesthesiologists physical status (ASA) I-II
Exclusion Criteria
* Ulnocarpal/pancarpal arthritis
* Lunate fossa, proximal lunate arthrosis or both
* Age \<18 or \>75 years
* Rheumatoid arthritis
* Heavy smoking (\> 20 cigarettes per day)
* Condition or medication affecting bony healing (eg diabetes mellitus with poor glycemic control, malnutrition, use of per oral corticosteroids)
* Alcohol or drug abuse
* Neurological condition affecting upper limb function
18 Years
75 Years
ALL
No
Sponsors
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Tampere University Hospital
OTHER
Turku University Hospital
OTHER_GOV
Jyväskylä Central Hospital
OTHER
Kymenlaakso Central Hospital Kotka Finland
OTHER
Töölö Hospital
OTHER
Responsible Party
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Samuli Aspinen
Principal investigator
Locations
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Töölö Hospital (Helsinki University Hospital)
Helsinki, , Finland
Central Hospital of Central Finland
Jyväskylä, , Finland
Kymenlaakso Central Hospital
Kotka, , Finland
Tampere University Hospital
Tampere, , Finland
Turku University Hospital
Turku, , Finland
Countries
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Central Contacts
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Facility Contacts
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Teemu Karjalainen, MD, PhD
Role: primary
Kaj Zilliacus, MD
Role: primary
Veera Pikkarainen, MD
Role: primary
Hanna-Stiina Taskinen, MD, PhD
Role: primary
References
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Alanen M, Stjernberg-Salmela S, Waris E, Karjalainen T, Miettunen J, Ryhanen J, Aspinen S. Proximal ROw carpectOmy versus four-corner Fusion (PROOF-trial) for osteoarthritis of the wrist: study protocol for multi-institutional double-blinded randomized controlled trial. Trials. 2023 Aug 7;24(1):499. doi: 10.1186/s13063-023-07544-1.
Other Identifiers
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HUS/3487/2019
Identifier Type: -
Identifier Source: org_study_id
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