NCT04260165 Proximal Row Carpectomy vs Four-corner Fusion for Osteoarthritis of the Wrist
| NCT ID | NCT04260165 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Töölö Hospital |
| Condition | Wrist Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2020-10-01 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 84 participants in total. It began in 2020-10-01 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Study purpose is to compare the outcome after proximal row carpectomy (PRC) vs four-corner fusion (FCA) for SLAC/SNAC II-III type osteoarthritis (OA) in a double-blinded randomized controlled study setting. 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.
Eligibility Criteria
Inclusion Criteria: * SLAC/SNAC II-III * Age 18 - 75 * Symptom duration \> 3 months * American Society of Anaesthesiologists physical status (ASA) I-II Exclusion Criteria: * Patient eligible for SL reconstruction or scaphoid * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04260165 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Wrist Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04260165 currently recruiting?
Yes, NCT04260165 is actively recruiting participants. Contact the research team at samuli.aspinen@hus.fi for enrollment information.
Where is the NCT04260165 trial being conducted?
This trial is being conducted at Helsinki, Finland, Jyväskylä, Finland, Kotka, Finland, Tampere, Finland and 1 additional location.
Who is sponsoring the NCT04260165 clinical trial?
NCT04260165 is sponsored by Töölö Hospital. The trial plans to enroll 84 participants.