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

NCT ID: NCT02827006

Last Updated: 2024-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2011-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Dorsal Malunion of the Distal Radius

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

the standard treatment is a corrective osteotomy with bone graft. The intervention in parallel group is a corrective osteotomy and use of CaP bone cement
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bone graft

Bone graft from iliac crest as gapfiller

Group Type ACTIVE_COMPARATOR

corrective osteotomy distal radius

Intervention Type PROCEDURE

Opening wedge corrective osteotomy on dorsal malunions of the distal radius. Distraction and correction of deformity.

Calcium phosphate bone cement

CaP bone cement as gapfiller

Group Type EXPERIMENTAL

corrective osteotomy distal radius

Intervention Type PROCEDURE

Opening wedge corrective osteotomy on dorsal malunions of the distal radius. Distraction and correction of deformity.

Interventions

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corrective osteotomy distal radius

Opening wedge corrective osteotomy on dorsal malunions of the distal radius. Distraction and correction of deformity.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mona Winge

Consultant, Orthopaedic Surgeon, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Magne Røkkum, MD PhD

Role: STUDY_DIRECTOR

OUS RH

Other Identifiers

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06/8465

Identifier Type: -

Identifier Source: org_study_id

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