Bone Graft Necessity in Opening-Wedge High Tibial Osteotomy

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Procedure: high tibial osteotomy; Procedure: higi tibial osteotomy

• Registration Number: NCT00786942
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-04
• Primary Completion: 2008-04
• Study First Submitted: 2008-11-05
• Study First Submitted QC: 2008-11-05
• Study First Posted: 2008-11-06
• Study Completion: 2009-04
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-21
• Last Update Posted: 2010-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• varus knee deformity
• unicompartmental arthrosis

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	high tibial osteotomy	autologous bone graft
2	higi tibial osteotomy	without bone graft

Primary Outcome Measures

Name	Time	Method
Clinical based bone union time	after 8 weeks

Secondary Outcome Measures

Name	Time	Method
X-ray femoro-tibial angle	6 months, 1 year

Trial Locations

Locations (1)

Departamento de Ortopedia do Hospital de Clínicas da Unicamp; 🇧🇷 Campinas, São Paulo, Brazil