Bone Graft Necessity in Opening-Wedge High Tibial Osteotomy
This study has been completed.
Sponsor:
University of Campinas, Brazil
Information provided by:
University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT00786942
First received: November 5, 2008
Last updated: May 21, 2010
Last verified: May 2010
| Tracking Information | |||||||||
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| First Received Date ICMJE | November 5, 2008 | ||||||||
| Last Updated Date | May 21, 2010 | ||||||||
| Start Date ICMJE | April 2006 | ||||||||
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Clinical based bone union time [ Time Frame: after 8 weeks ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00786942 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
X-ray femoro-tibial angle [ Time Frame: 6 months, 1 year ] [ Designated as safety issue: Yes ] | ||||||||
| 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 | Bone Graft Necessity in Opening-Wedge High Tibial Osteotomy | ||||||||
| Official Title ICMJE | Bone Graft Necessity in Opening-Wedge High Tibial Osteotomy. A Randomized Clinical Trial | ||||||||
| Brief Summary | The purpose of this study is to determine wether autologous bone graft from iliac crest enhances bone union of tibial osteotomies, in the treatment of varus knee deformity. |
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| Detailed Description | Opening-Wedge High Tibial Osteotomy is a classic procedure,but the use of autologous bone graft from iliac crest causes pain and bleeding. Bone union occur even without bone graft, but no clinical trials compared results of the twoo procedures. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Osteoarthritis | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| 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 | Completed | ||||||||
| Estimated Enrollment ICMJE | 44 | ||||||||
| Completion Date | April 2009 | ||||||||
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 20 Years to 60 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Brazil | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00786942 | ||||||||
| Other Study ID Numbers ICMJE | Puddu | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Alessandro Rozim Zorzi, Unicamp | ||||||||
| Study Sponsor ICMJE | University of Campinas, Brazil | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Campinas, Brazil | ||||||||
| Verification Date | May 2010 | ||||||||
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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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