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Completed

NCT Number: NCT02827006

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

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

corrective osteotomy distal radius

Procedure

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

Primary outcomes

  1. volar angulation distal radius, x-ray

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jul 11, 2016
Registry last updated
May 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.