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

CaP Cement is Equivalent to Iliac Bone Graft in Filling of Large Metaphyseal Defects: A 2 Year Prospective Randomised Study on Distal Radius Osteotomies

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

Study Overview

• Status: Completed
• Conditions: Dorsal Malunion of the Distal Radius
• Intervention / Treatment: Procedure: corrective osteotomy distal radius

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bone graft; Bone graft from iliac crest as gapfiller	Procedure: corrective osteotomy distal radius; Opening wedge corrective osteotomy on dorsal malunions of the distal radius. Distraction and correction of deformity.
Experimental: Calcium phosphate bone cement; CaP bone cement as gapfiller	Procedure: corrective osteotomy distal radius; Opening wedge corrective osteotomy on dorsal malunions of the distal radius. Distraction and correction of deformity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
volar angulation distal radius, x-ray	24 months

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Study Director: Magne Røkkum, MD PhD, OUS RH

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: June 27, 2016
• First Submitted That Met QC Criteria: July 5, 2016
• First Posted (Estimated): July 11, 2016

Study Record Updates

• Last Update Posted (Actual): May 6, 2024
• Last Update Submitted That Met QC Criteria: May 3, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: RCT; CT; Bone graft; Calcium phosphate bone cement; Xray
• Other Study ID Numbers: 06/8465

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES