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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00200603
Recruitment Status : Unknown
Verified May 2004 by Nantes University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 20, 2005
Last Update Posted : December 16, 2005
Sponsor:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment
Osteoarthritis of the Knee Device: calcium phosphate macroporous bioceramics

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autograft Versus Calcium Phosphate Macroporous Bioceramics as Bone Substitute for Tibial Valgus Osteotomy
Study Start Date : May 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Radiological healing and stability of the osteotomy measure at 3, 6, 12 and 24 months after surgery

Secondary Outcome Measures :
  1. Knee and iliac crest painSurgical complicationsFonctional results

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: December 16, 2005
Last Verified: May 2004

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