Bone Graft Necessity in Opening-Wedge High Tibial Osteotomy

NCT ID: NCT00786942

Last Updated: 2010-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2009-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

autologous bone graft

Group Type ACTIVE_COMPARATOR

high tibial osteotomy

Intervention Type PROCEDURE

addition of bone graft to fill the osteotomy gap

2

without bone graft

Group Type EXPERIMENTAL

higi tibial osteotomy

Intervention Type PROCEDURE

the gap of the tibia is unfilled

Interventions

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high tibial osteotomy

addition of bone graft to fill the osteotomy gap

Intervention Type PROCEDURE

higi tibial osteotomy

the gap of the tibia is unfilled

Intervention Type PROCEDURE

Other Intervention Names

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opening-wedge higi tibial osteotomy opening-wedge higi tibial osteotomy

Eligibility Criteria

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Inclusion Criteria

* varus knee deformity
* unicompartmental arthrosis

Exclusion Criteria

* patellar arthrosis
* lateral arthrosis
* inflammatory diseases
* bone healing impair drugs or diseases
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Campinas, Brazil

OTHER

Sponsor Role lead

Responsible Party

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Unicamp

Principal Investigators

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Alessandro R Zorzi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Campinas, Brazil

João B Miranda, MD, PhD

Role: STUDY_CHAIR

University of Campinas, Brazil

Locations

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Departamento de Ortopedia do Hospital de Clínicas da Unicamp

Campinas, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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Puddu

Identifier Type: -

Identifier Source: org_study_id

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