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

January 5, 2008
May 22, 2010
September 2007
February 2008   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00595712 on ClinicalTrials.gov Archive Site
Not Provided
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Results of Opening-wedge High Tibial Osteotomy Using Iliac Crest Allograft Compared to Iliac Crest Autograft
Not Provided

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Genovarum
  • Procedure: Iliac crest allograft
    Opening wedge osteotomy of proximal tibia with allograft from iliac crest
  • Procedure: Iliac crest autograft
    open wedge osteotomy of proximal tibia using autogenous iliac bone graft
  • Active Comparator: A
    Using Iliac crest allograft in high tibial osteotomy
    Intervention: Procedure: Iliac crest allograft
  • Active Comparator: B
    Using iliac crest autograft in high tibial osteotomy
    Intervention: Procedure: Iliac crest autograft
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
February 2010
February 2008   (final data collection date for primary outcome measure)

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
Both
16 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT00595712
86-09-30-4111
Yes
Ramin Espandar/Assistant Professor, TehranUMS
Tehran University of Medical Sciences
Not Provided
Study Director: Seyyed Mohammad J Mortazavi, M.D. Tehran University of Medical Sciences
Tehran University of Medical Sciences
May 2010

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