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NCT00786942 Clinical Trial

Bone Graft Necessity in Opening-Wedge High Tibial Osteotomy

Osteoarthritis Clinical Trial

Official title:
Bone Graft Necessity in Opening-Wedge High Tibial Osteotomy. A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00786942
Other study ID # Puddu
Secondary ID
Status Completed
Phase N/A
First received November 5, 2008
Last updated May 21, 2010
Start date April 2006
Est. completion date April 2009

Study information
Verified date May 2010
Source University of Campinas, Brazil
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date April 2009
Est. primary completion date April 2008
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria:

- varus knee deformity

- unicompartmental arthrosis

Exclusion Criteria:

- patellar arthrosis

- lateral arthrosis

- inflammatory diseases

- bone healing impair drugs or diseases

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• high tibial osteotomy
addition of bone graft to fill the osteotomy gap
• higi tibial osteotomy
the gap of the tibia is unfilled

Locations
Country Name City State
Brazil Departamento de Ortopedia do Hospital de Clínicas da Unicamp Campinas São Paulo

Sponsors (1)
Lead Sponsor Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical based bone union time after 8 weeks Yes
Secondary X-ray femoro-tibial angle 6 months, 1 year Yes
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