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Bone Graft Necessity in Opening-Wedge High Tibial Osteotomy

This study has been completed.
Sponsor:
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

November 5, 2008
May 21, 2010
April 2006
April 2008   (final data collection date for primary outcome measure)
Clinical based bone union time [ Time Frame: after 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00786942 on ClinicalTrials.gov Archive Site
X-ray femoro-tibial angle [ Time Frame: 6 months, 1 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Bone Graft Necessity in Opening-Wedge High Tibial Osteotomy
Bone Graft Necessity in Opening-Wedge High Tibial Osteotomy. A Randomized Clinical Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis
  • Procedure: high tibial osteotomy
    addition of bone graft to fill the osteotomy gap
    Other Name: opening-wedge higi tibial osteotomy
  • Procedure: higi tibial osteotomy
    the gap of the tibia is unfilled
    Other Name: opening-wedge higi tibial osteotomy
  • Active Comparator: 1
    autologous bone graft
    Intervention: Procedure: high tibial osteotomy
  • Experimental: 2
    without bone graft
    Intervention: Procedure: higi tibial osteotomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
April 2009
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • varus knee deformity
  • unicompartmental arthrosis

Exclusion Criteria:

  • patellar arthrosis
  • lateral arthrosis
  • inflammatory diseases
  • bone healing impair drugs or diseases
Both
20 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00786942
Puddu
No
Alessandro Rozim Zorzi, Unicamp
University of Campinas, Brazil
Not Provided
Principal Investigator: Alessandro R Zorzi, MD University of Campinas, Brazil
Study Chair: João B Miranda, MD, PhD University of Campinas, Brazil
University of Campinas, Brazil
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP