Proximal Row Carpectomy vs Four-corner Fusion for Osteoarthritis of the Wrist
Recruiting · NCT04260165 · Interventional (participants receive a specific treatment) · Lead sponsor: Töölö Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
5 locations listed.
- 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