Proximal Row Carpectomy vs Four-corner Fusion for Osteoarthritis of the Wrist

Recruiting now · Not applicable

Conditions studied: Wrist Osteoarthritis, Scapholunate Advanced Collapse

In brief

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.

Key facts

Study ID

NCT04260165

Run by

Töölö Hospital

People needed

84

Starts

2020-10-01

Expected to finish

2034-12-31

Last updated by the study team

2021-01-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• SLAC/SNAC II-III
• Age 18 - 75
• Symptom duration > 3 months
• American Society of Anaesthesiologists physical status (ASA) I-II

You may not qualify if…

• 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

Where it is running

• Töölö Hospital (Helsinki University Hospital) — Helsinki, Finland (enrolling)
• Central Hospital of Central Finland — Jyväskylä, Finland
• Kymenlaakso Central Hospital — Kotka, Finland
• Tampere University Hospital — Tampere, Finland
• Turku University Hospital — Turku, Finland

Full record on ClinicalTrials.gov

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