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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00595712
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : May 25, 2010
Information provided by:
Tehran University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Genovarum Procedure: Iliac crest allograft Procedure: Iliac crest autograft Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2010

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Range of motion of the knee [ Time Frame: before op and at follow ups ]
  2. knee score (womac) [ Time Frame: before op and at final follow up ]

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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00595712

Iran, Islamic Republic of
Imam Khomeini Hospital
Tehran, Iran, Islamic Republic of, 1419173341
Sponsors and Collaborators
Tehran University of Medical Sciences
Study Director: Seyyed Mohammad J Mortazavi, M.D. Tehran University of Medical Sciences

Responsible Party: Ramin Espandar/Assistant Professor, TehranUMS Identifier: NCT00595712     History of Changes
Other Study ID Numbers: 86-09-30-4111
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: May 25, 2010
Last Verified: May 2010

Keywords provided by Tehran University of Medical Sciences:
Medial opening-wedge high tibial osteotomy