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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. The completion date has passed and the status has not been verified in more than two years.
Verified May 2004 by Nantes University Hospital.
Recruitment status was:  Active, not recruiting
Information provided by:
Nantes University Hospital Identifier:
First received: September 9, 2005
Last updated: December 15, 2005
Last verified: May 2004
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:

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

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00200603

Gouin François
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
Principal Investigator: François Gouin, MD Nantes UH
  More Information Identifier: NCT00200603     History of Changes
Other Study ID Numbers: BRD/99/3-G
Study First Received: September 9, 2005
Last Updated: December 15, 2005

Keywords provided by Nantes University Hospital:
Calcium phosphate ceramic
tibial osteotomy

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on April 28, 2017