Bone Graft Necessity in Opening-Wedge High Tibial Osteotomy

This study is currently recruiting participants.

Verified by University of Campinas, Brazil, November 2008

First Received: November 5, 2008 No Changes Posted

Sponsored by:	University of Campinas, Brazil
Information provided by:	University of Campinas, Brazil
ClinicalTrials.gov Identifier:	NCT00786942

Purpose

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	Intervention
Osteoarthritis	Procedure: high tibial osteotomy Procedure: higi tibial osteotomy

MedlinePlus related topics: Bone Grafts Osteoarthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Bone Graft Necessity in Opening-Wedge High Tibial Osteotomy. A Randomized Clinical Trial

Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:

Clinical based bone union time [ Time Frame: after 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

X-ray femoro-tibial angle [ Time Frame: 6 months, 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	44
Study Start Date:	April 2006
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator autologous bone graft	Procedure: high tibial osteotomy addition of bone graft to fill the osteotomy gap
2: Experimental without bone graft	Procedure: higi tibial osteotomy the gap of the tibia is unfilled

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.

Eligibility

Ages Eligible for Study:	20 Years to 60 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00786942

Contacts

Contact: Alessandro R Zorzi, MD	551935217505	zorzi@fcm.unicamp.br
Contact: João B Miranda, MD, PhD	551935217505	jotamiran@yahoo.com.br

Locations

Brazil, São Paulo
Departamento de Ortopedia do Hospital de Clínicas da Unicamp	Recruiting
Campinas, São Paulo, Brazil, 13084-971
Principal Investigator: Alessandro R Zorzi, MD

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

More Information

No publications provided

Responsible Party:	Unicamp ( Alessandro Rozim Zorzi )
Study ID Numbers:	Puddu
Study First Received:	November 5, 2008
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00786942 History of Changes
Health Authority:	Brazil: Ethics Committee

Keywords provided by University of Campinas, Brazil:

osteotomy
knee
varus deformity
bone graft

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases

Arthritis
Rheumatic Diseases
Congenital Abnormalities

Additional relevant MeSH terms:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 07, 2009