NCT04260165

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

A Double-blinded Randomized Controlled Multicenter Trial Comparing Proximal ROw carpectOmy and Four-corner Fusion (PROOF) for Osteoarthritis of the Wrist

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Töölö Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wrist Osteoarthritis
• Scapholunate Advanced Collapse

Interventions

Type	Name	Description
PROCEDURE	Proximal Row Carpectomy	Excision of the proximal carpal row - the scaphoid, lunate and triquetrum
PROCEDURE	Four-corner fusion	Scaphoid excision and four-corner fusion with cannulated headless compression screws/dorsal plate

Timeline

• Start date: 2020-10-01
• Primary completion: 2024-12-31
• Completion: 2034-12-31
• First posted: 2020-02-07
• Last updated: 2021-01-19

Locations

5 sites across 1 country: Finland