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

Tracking Information

First Received Date ^ICMJE

January 5, 2008

Last Updated Date

October 4, 2009

Start Date ^ICMJE

September 2007

Estimated Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00595712 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment

Condition ^ICMJE

Genovarum

Intervention ^ICMJE

Procedure: Iliac crest allograft
Procedure: Iliac crest autograft

Study Arms / Comparison Groups

Active Comparator: Using Iliac crest allograft in high tibial osteotomy
Active Comparator: Using iliac crest autograft in high tibial osteotomy

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2009

Estimated Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

16 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Iran, Islamic Republic of

Administrative Information

NCT ID ^ICMJE

NCT00595712

Responsible Party

Ramin Espandar/Assistant Professor, TehranUMS

Study ID Numbers ^ICMJE

86-09-30-4111

Study Sponsor ^ICMJE

Tehran University of Medical Sciences

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Seyyed Mohammad J Mortazavi, M.D.

Tehran University of Medical Sciences

Information Provided By

Tehran University of Medical Sciences

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP