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

This study is ongoing, but not recruiting participants.

Sponsored by:	Nantes University Hospital
Information provided by:	Nantes University Hospital
ClinicalTrials.gov Identifier:	NCT00200603

Purpose

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.

Condition	Intervention
Osteoarthritis of the Knee	Device: calcium phosphate macroporous bioceramics

MedlinePlus related topics: Calcium Osteoarthritis

Drug Information available for: Calcium gluconate Calcium phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Autograft Versus Calcium Phosphate Macroporous Bioceramics as Bone Substitute for Tibial Valgus Osteotomy

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:

Radiological healing and stability of the osteotomy measure at 3, 6, 12 and 24 months after surgery

Secondary Outcome Measures:

Knee and iliac crest painSurgical complicationsFonctional results

Estimated Enrollment:	50
Study Start Date:	May 1999

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200603

Locations

France
Gouin François
Nantes, France, 44093

Sponsors and Collaborators

Nantes University Hospital

Investigators

Principal Investigator:

François Gouin, MD

Nantes UH

More Information

Study ID Numbers:	BRD/99/3-G
Study First Received:	September 9, 2005
Last Updated:	December 15, 2005
ClinicalTrials.gov Identifier:	NCT00200603
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Nantes University Hospital:

Calcium phosphate ceramic
tibial osteotomy
osteoarthritis

Study placed in the following topic categories:

Calcium, Dietary
Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 16, 2009