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

Phase 4
Completed
Conditions
Dorsal Malunion of the Distal Radius
Interventions
Procedure: corrective osteotomy 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.

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
Arm && Interventions
GroupInterventionDescription
Bone graftcorrective osteotomy distal radiusBone graft from iliac crest as gapfiller
Calcium phosphate bone cementcorrective osteotomy distal radiusCaP bone cement as gapfiller
Primary Outcome Measures
NameTimeMethod
volar angulation distal radius, x-ray24 months
Secondary Outcome Measures
NameTimeMethod
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