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CompletedNCT02827006Updated May 6, 2024

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

A Phase 4 interventional study of corrective osteotomy distal radius in Dorsal Malunion of the Distal Radius, sponsored by Oslo University Hospital. Completed. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-06.

Sponsored by Oslo University Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Dorsal Malunion of the Distal Radius

Keywords

  • Bone graft
  • Calcium phosphate bone cement
  • RCT
  • Xray
  • CT
03

In context

Lead sponsor

Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • distal radius malunion with dorsal deformity, disability and pain.

Exclusion criteria

Exclusion Criteria:

  • age under 18 years, bad health, inflammatory arthritis and radio-carpal osteoarthritis.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    Bone graft

    Bone graft from iliac crest as gapfiller

    Procedure: corrective osteotomy distal radius

  • Experimental
    Calcium phosphate bone cement

    CaP bone cement as gapfiller

    Procedure: corrective osteotomy distal radius

Interventions

  • Procedurecorrective osteotomy distal radius

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

06

What researchers measure

Primary outcomes

  1. volar angulation distal radius, x-ray

    Time frame: 24 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02827006
Lead sponsor
Oslo University Hospital
Responsible party
Mona Winge (Consultant, Orthopaedic Surgeon, Principal Investigator, Oslo University Hospital) — Principal investigator
First posted
Jul 11, 2016
Start date
Jan 2007
Primary completion
May 2011
Completion
May 2011
Last update
May 6, 2024

Study contacts

Magne Røkkum, MD PhD
study director · OUS RH

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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