Results of Opening-wedge High Tibial Osteotomy Using Iliac Crest Allograft Compared to Iliac Crest Autograft

This study is ongoing, but not recruiting participants.

First Received: January 5, 2008 Last Updated: October 4, 2009 History of Changes

Sponsor:	Tehran University of Medical Sciences
Information provided by:	Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00595712

Purpose

The purpose of this RCT is to determine the results of opening-wedge high tibial osteotomy in patients with genovarum deformity using iliac crest allograft compared to the results when using iliac crest autograft.

Condition	Intervention	Phase
Genovarum	Procedure: Iliac crest allograft Procedure: Iliac crest autograft	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:

Range of motion of the knee [ Time Frame: before op and at follow ups ] [ Designated as safety issue: No ]
knee score (womac) [ Time Frame: before op and at final follow up ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	September 2007
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Using Iliac crest allograft in high tibial osteotomy	Procedure: Iliac crest allograft Opening wedge osteotomy of proximal tibia with allograft from iliac crest
B: Active Comparator Using iliac crest autograft in high tibial osteotomy	Procedure: Iliac crest autograft open wedge osteotomy of proximal tibia using autogenous iliac bone graft

Eligibility

Ages Eligible for Study:	16 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Varus malalignment of knee with of without osteoarthritis: the angle between the articular surface and anatomical axis of tibia< 82 degrees
at least 7.5 mm opening wedge is needed in medial proximal tibia to correct the deformity assessed during pre-op planning

Exclusion Criteria:

symptomatic lateral compartment osteoarthritis of knee
rheumatoid arthritis or other inflammatory joint diseases
less than 100 degrees of knee range of motion
grade III laxity in knee collateral ligaments
history of surgery or fracture in the limb
>15 degrees flexion contracture
age <16 or >60 years
>20 degrees varus deformity
failure to attend follow-up visits
sever bone loss in medial tibial plateau or medial femoral condyle
>1cm joint subluxation
presence of lateral trust during walking
presence of patella baja
skin derangements on medial proximal tibia
any form of nicotine addiction

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595712

Locations

Iran, Islamic Republic of
Imam Khomeini Hospital
Tehran, Iran, Islamic Republic of, 1419173341

Sponsors and Collaborators

Tehran University of Medical Sciences

Investigators

Study Director:

Seyyed Mohammad J Mortazavi, M.D.

Tehran University of Medical Sciences

More Information

No publications provided

Responsible Party:	TehranUMS ( Ramin Espandar/Assistant Professor )
Study ID Numbers:	86-09-30-4111
Study First Received:	January 5, 2008
Last Updated:	October 4, 2009
ClinicalTrials.gov Identifier:	NCT00595712 History of Changes
Health Authority:	Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:

Genovarum
Medial opening-wedge high tibial osteotomy
allograft

ClinicalTrials.gov processed this record on November 27, 2009