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

This study has been completed.
Sponsor:
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00595712
First received: January 5, 2008
Last updated: May 22, 2010
Last verified: May 2010
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

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
Study Completion Date: February 2010
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Using Iliac crest allograft in high tibial osteotomy
Procedure: Iliac crest allograft
Opening wedge osteotomy of proximal tibia with allograft from iliac crest
Active Comparator: B
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: Ramin Espandar/Assistant Professor, TehranUMS
ClinicalTrials.gov Identifier: NCT00595712     History of Changes
Other Study ID Numbers: 86-09-30-4111
Study First Received: January 5, 2008
Last Updated: May 22, 2010
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 April 16, 2014