Bone Graft Necessity in Opening-Wedge High Tibial Osteotomy

May 21, 2010 updated by: University of Campinas, Brazil

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Campinas, São Paulo, Brazil, 13084-971
        • Departamento de Ortopedia do Hospital de Clínicas da Unicamp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • varus knee deformity
  • unicompartmental arthrosis

Exclusion Criteria:

  • patellar arthrosis
  • lateral arthrosis
  • inflammatory diseases
  • bone healing impair drugs or diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
autologous bone graft
Procedure: high tibial osteotomy
addition of bone graft to fill the osteotomy gap
Other Names:
  • opening-wedge higi tibial osteotomy
Experimental: 2
without bone graft
Procedure: higi tibial osteotomy
the gap of the tibia is unfilled
Other Names:
  • opening-wedge higi tibial osteotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical based bone union time
Time Frame: after 8 weeks
after 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
X-ray femoro-tibial angle
Time Frame: 6 months, 1 year
6 months, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

November 5, 2008

First Submitted That Met QC Criteria

November 5, 2008

First Posted (Estimate)

November 6, 2008

Study Record Updates

Last Update Posted (Estimate)

May 24, 2010

Last Update Submitted That Met QC Criteria

May 21, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Puddu

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoarthritis

Clinical Trials on high tibial osteotomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe