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Bone Graft Necessity in Opening-Wedge High Tibial Osteotomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00786942
First Posted: November 6, 2008
Last Update Posted: May 24, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Campinas, Brazil
  Purpose
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.

Condition Intervention
Osteoarthritis Procedure: high tibial osteotomy Procedure: higi tibial osteotomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bone Graft Necessity in Opening-Wedge High Tibial Osteotomy. A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • Clinical based bone union time [ Time Frame: after 8 weeks ]

Secondary Outcome Measures:
  • X-ray femoro-tibial angle [ Time Frame: 6 months, 1 year ]

Estimated Enrollment: 44
Study Start Date: April 2006
Study Completion Date: April 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
autologous bone graft
Procedure: high tibial osteotomy
addition of bone graft to fill the osteotomy gap
Other Name: opening-wedge higi tibial osteotomy
Experimental: 2
without bone graft
Procedure: higi tibial osteotomy
the gap of the tibia is unfilled
Other Name: opening-wedge higi tibial osteotomy

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.
  Eligibility

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • varus knee deformity
  • unicompartmental arthrosis

Exclusion Criteria:

  • patellar arthrosis
  • lateral arthrosis
  • inflammatory diseases
  • bone healing impair drugs or diseases
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00786942


Locations
Brazil
Departamento de Ortopedia do Hospital de Clínicas da Unicamp
Campinas, São Paulo, Brazil, 13084-971
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
Principal Investigator: Alessandro R Zorzi, MD University of Campinas, Brazil
Study Chair: João B Miranda, MD, PhD University of Campinas, Brazil
  More Information

Responsible Party: Alessandro Rozim Zorzi, Unicamp
ClinicalTrials.gov Identifier: NCT00786942     History of Changes
Other Study ID Numbers: Puddu
First Submitted: November 5, 2008
First Posted: November 6, 2008
Last Update Posted: May 24, 2010
Last Verified: May 2010

Keywords provided by University of Campinas, Brazil:
osteotomy
knee
varus deformity
bone graft

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases