Bone Graft Necessity in Opening-Wedge High Tibial Osteotomy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00786942

Enrollment

Registered

2008-11-06

Start date

2006-04-30

Completion date

2009-04-30

Last updated

2010-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

osteotomy, knee, varus deformity, bone graft

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.

Interventions

PROCEDUREhigh tibial osteotomy

addition of bone graft to fill the osteotomy gap

PROCEDUREhigi tibial osteotomy

the gap of the tibia is unfilled

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

Inclusion criteria

* varus knee deformity * unicompartmental arthrosis

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Clinical based bone union time	after 8 weeks

Secondary

Measure	Time frame
X-ray femoro-tibial angle	6 months, 1 year

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026