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

University of Oslo (UIO)

Status and phase: Completed; Phase 4

Conditions: Dorsal Malunion of the Distal Radius

Treatments: Procedure: corrective osteotomy distal radius

Study type: Interventional

Funder types: Other

Identifiers

NCT02827006

06/8465

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Bone graft

Active Comparator group

Description:

Bone graft from iliac crest as gapfiller

Treatment:

Procedure: corrective osteotomy distal radius

Calcium phosphate bone cement

Experimental group

Description:

CaP bone cement as gapfiller

Treatment:

Procedure: corrective osteotomy distal radius