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OpenTrials
Completed

NCT Number: NCT00595712

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

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.

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Key information

Conditions

Genovarum

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Imam Khomeini Hospital

Tehran, 1419173341, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iliac crest allograft

Procedure

Opening wedge osteotomy of proximal tibia with allograft from iliac crest

Iliac crest autograft

Procedure

open wedge osteotomy of proximal tibia using autogenous iliac bone graft

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2010
First posted
Jan 16, 2008
Registry last updated
May 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.