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

• Sponsor: Nantes University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00200603
• Collaborator: (none)
• Enrollment: 50
• Location: 1

Study Details

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	Phase
Osteoarthritis of the Knee	Device: calcium phosphate macroporous bioceramics	N/A

Study Design

• Study Type: Interventional
• 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 1, 1999

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

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	Gouin François	Nantes		France	44093

Sponsors and Collaborators

• Nantes University Hospital

Investigators

• Principal Investigator: François Gouin, MD, Nantes UH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00200603
• Other Study ID Numbers: BRD/99/3-G
• First Posted: Sep 20, 2005
• Last Update Posted: Dec 16, 2005
• Last Verified: May 1, 2004

• Keywords provided by , ,: Calcium phosphate ceramic; tibial osteotomy; osteoarthritis
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Calcium

Study Results

No Results Posted as of Dec 16, 2005