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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2004 by Nantes University Hospital.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Nantes University Hospital

ClinicalTrials.gov Identifier:

NCT00200603

First received: September 9, 2005

Last updated: December 15, 2005

Last verified: May 2004

History of Changes

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Autograft Versus Calcium Phosphate Macroporous Bioceramics as Bone Substitute for Tibial Valgus Osteotomy

Resource links provided by NLM:

MedlinePlus related topics: Calcium Osteoarthritis

Drug Information available for: Calcium Gluconate

U.S. FDA Resources

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 (Adult, Senior)
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

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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


ClinicalTrials.gov Identifier:	NCT00200603 History of Changes
Other Study ID Numbers:	BRD/99/3-G
Study First Received:	September 9, 2005
Last Updated:	December 15, 2005
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:


Calcium phosphate ceramic tibial osteotomy osteoarthritis

Additional relevant MeSH terms:


Osteoarthritis Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases	Rheumatic Diseases Calcium, Dietary Bone Density Conservation Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 28, 2016

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