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NCT00200603 Clinical Trial

Autograft Versus Calcium Phosphate Macroporous Bioceramics as Bone Substitute for Tibial Valgus Osteotomy

Osteoarthritis of the Knee Clinical Trial

Official title:
Autograft Versus Calcium Phosphate Macroporous Bioceramics as Bone Substitute for Tibial Valgus Osteotomy

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00200603
Other study ID # BRD/99/3-G
Secondary ID
Status Active, not recruiting
Phase N/A
First received September 9, 2005
Last updated December 15, 2005
Start date May 1999

Study information
Verified date May 2004
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

The aim of the study is to compare radiological behavior of blocks of macroporous phosphocalcium as bone substitute in comparison with iliac crest autograft in tibial valgus osteotomy.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 50
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- knee osteoarthritis eligible for tibial valgus osteotomy

- > 18 y.o

Exclusion Criteria:

- prior tibial osteotomy

- history of local infection

- rheumatoid and other inflammatory arthritis

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• calcium phosphate macroporous bioceramics

Locations
Country Name City State
France Gouin François Nantes

Sponsors (1)
Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Radiological healing and stability of the osteotomy measure at 3, 6, 12 and 24 months after surgery
Secondary Knee and iliac crest painSurgical complicationsFonctional results
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