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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:

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
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

No publications provided

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013