CaP Cement is Equivalent to Iliac Bone Graft in Filling of Large Metaphyseal Defects

Phase 4

Completed

• Conditions: Dorsal Malunion of the Distal Radius

• Registration Number: NCT02827006
• Lead Sponsor: Oslo University Hospital

Brief Summary

CaP Cement is Equivalent to Iliac Bone Graft in Filling of Large Metaphyseal Defects

Detailed Description

Background: A bone graft from the iliac crest has long been the gold standard for filling voids in opening wedge osteotomies. CaP bone cement has been considered the possible alternative to bone graft.

Methods: 20 adult patients with distal radius malunions and dorsal deformities were randomised intra-operatively to bone graft (10) or CaP bone cement (10). Dorsal titanium locking plates were used and the wrist was stabilised in a cast for 8 weeks. Follow-ups for 24 months included VAS on wrist and iliac crest, grip strength, ROM bilaterally, Quick-DASH and Gartland \& Werley's functional scoring system. X-rays and CT scans were taken at 8 wks, 3-6-12-24 mths.

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-07-05
• Study First Posted: 2016-07-11
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• distal radius malunion with dorsal deformity, disability and pain.

Exclusion Criteria

• age under 18 years, bad health, inflammatory arthritis and radio-carpal osteoarthritis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
volar angulation distal radius, x-ray	24 months