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

Töölö Hospital

Status

Enrolling

Conditions

Scapholunate Advanced Collapse

Wrist Osteoarthritis

Treatments

Procedure: Four-corner fusion

Procedure: Proximal Row Carpectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT04260165

HUS/3487/2019

Details and patient eligibility

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.

Enrollment

84 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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