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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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Clinical based bone union time [ Time Frame: after 8 weeks ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Alessandro Rozim Zorzi, Unicamp
ClinicalTrials.gov Identifier: NCT00786942     History of Changes
Other Study ID Numbers: Puddu
Study First Received: November 5, 2008
Last Updated: May 21, 2010
Health Authority: Brazil: Ethics Committee

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

ClinicalTrials.gov processed this record on June 18, 2013