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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 20, 2014