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Bone Graft Necessity in Opening-Wedge High Tibial Osteotomy

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ClinicalTrials.gov Identifier: NCT00786942
Recruitment Status : Completed
First Posted : November 6, 2008
Last Update Posted : May 24, 2010
Sponsor:
Information provided by:
University of Campinas, Brazil

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.

Condition or disease Intervention/treatment
Osteoarthritis Procedure: high tibial osteotomy Procedure: 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
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
Study Start Date : April 2006
Primary Completion Date : April 2008
Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts
U.S. FDA Resources

Arm Intervention/treatment
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



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

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


Information from the National Library of Medicine

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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

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

Responsible Party: Alessandro Rozim Zorzi, Unicamp
ClinicalTrials.gov Identifier: NCT00786942     History of Changes
Other Study ID Numbers: Puddu
First Posted: November 6, 2008    Key Record Dates
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