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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02827006
Enrollment
20
Registered
2016-07-11
Start date
2007-01-31
Completion date
2011-05-31
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dorsal Malunion of the Distal Radius

Keywords

Bone graft, Calcium phosphate bone cement, RCT, Xray, CT

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.

Interventions

PROCEDUREcorrective osteotomy distal radius

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

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
volar angulation distal radius, x-ray24 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026