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Completed

NCT Number: NCT00786942

Bone Graft Necessity in Opening-Wedge High Tibial Osteotomy

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Departamento de Ortopedia do Hospital de Clínicas da Unicamp

Campinas, São Paulo, 13084-971, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • varus knee deformity
  • unicompartmental arthrosis

Exclusion criteria

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

Treatment and study plan

High tibial osteotomy

Procedure

addition of bone graft to fill the osteotomy gap

Other names: opening-wedge higi tibial osteotomy

higi tibial osteotomy

Procedure

the gap of the tibia is unfilled

Other names: opening-wedge higi tibial osteotomy

Primary outcomes

  1. Clinical based bone union time

    Time frame: after 8 weeks

Secondary outcomes

  1. X-ray femoro-tibial angle

    Time frame: 6 months, 1 year

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Nov 6, 2008
Registry last updated
May 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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