NCT04403958

The Use of Proximal Carpal Row Versus Iliac Crest as Bone Graft in Total Wrist Fusion

The Use of Proximal Carpal Row Versus Iliac Crest Bone Graft in Total Wrist Fusion - a Randomized Controlled Multicenter Trial Comparing Two Operative Techniques (PROOF II - Trial)

• Status: Unknown
• 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 total wrist arthrodesis (TWA) with proximal carpal row (Proximal Row Carpectomy = PRC) as bone graft versus iliac crest cancellous bone graft. Patients with radiologically and clinically confirmed advanced osteoarthritis are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo either total wrist arthrodesis with PRC or TWA with iliac crest bone grafting. Baseline data is collected preoperatively and is a follow-up visits at every 6 weeks after the surgery is arranged until the wrist is fused. The primary end-point is 6 months and the primary outcome is fusion rate.

Conditions

• Wrist Arthritis
• Fusion; Joint

Interventions

Type	Name	Description
PROCEDURE	PRC	Total wrist arthrodesis with dorsal plate using proximal row of the wrist as bone graft
PROCEDURE	TWA	Total wrist arthrodesis with dorsal plate using iliac crest as bone graft

Timeline

• Start date: 2021-09-01
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2020-05-27
• Last updated: 2021-03-30