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

Primary Purpose

Osteoarthritis of the Knee

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

calcium phosphate macroporous bioceramics

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring Calcium phosphate ceramic, tibial osteotomy, osteoarthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Gouin François

Outcomes

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

Full Information

NCT ID

NCT00200603

First Posted

September 9, 2005

Last Updated

December 15, 2005

Sponsor

Nantes University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00200603

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2004

Overall Recruitment Status

Unknown status

Study Start Date

May 1999 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Nantes University Hospital

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis of the Knee

Keywords

Calcium phosphate ceramic, tibial osteotomy, osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (false)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

calcium phosphate macroporous bioceramics

Primary Outcome Measure Information:

Title

Radiological healing and stability of the osteotomy measure at 3, 6, 12 and 24 months after surgery

Secondary Outcome Measure Information:

Title

Knee and iliac crest painSurgical complicationsFonctional results

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

François Gouin, MD

Organizational Affiliation

Nantes UH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gouin François

City

Nantes

ZIP/Postal Code

44093

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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