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
Recruitment status was Active, not recruiting
Sponsor:
Nantes University Hospital
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00200603
First received: September 9, 2005
Last updated: December 15, 2005
Last verified: May 2004
| Tracking Information | |||||
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| First Received Date ICMJE | September 9, 2005 | ||||
| Last Updated Date | December 15, 2005 | ||||
| Start Date ICMJE | May 1999 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Radiological healing and stability of the osteotomy measure at 3, 6, 12 and 24 months after surgery | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00200603 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Knee and iliac crest painSurgical complicationsFonctional results | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Autograft Versus Calcium Phosphate Macroporous Bioceramics as Bone Substitute for Tibial Valgus Osteotomy | ||||
| Official Title ICMJE | Autograft Versus Calcium Phosphate Macroporous Bioceramics as Bone Substitute for Tibial Valgus Osteotomy | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Osteoarthritis of the Knee | ||||
| Intervention ICMJE | Device: calcium phosphate macroporous bioceramics | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 50 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00200603 | ||||
| Other Study ID Numbers ICMJE | BRD/99/3-G | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Nantes University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Nantes University Hospital | ||||
| Verification Date | May 2004 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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