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CompletedNCT00595712Updated May 25, 2010

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

A Phase 3 interventional study of Iliac crest allograft and Iliac crest autograft in Genovarum, sponsored by Tehran University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 16 Years to 60 Years. Per ClinicalTrials.gov, last updated 2010-05-25.

Sponsored by Tehran University of Medical Sciences · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
16 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Genovarum

Keywords

  • Genovarum
  • Medial opening-wedge high tibial osteotomy
  • allograft
03

In context

Lead sponsor

Tehran University of Medical Sciences is the lead sponsor of 227 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 60 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    A

    Using Iliac crest allograft in high tibial osteotomy

    Procedure: Iliac crest allograft

  • Active comparator
    B

    Using iliac crest autograft in high tibial osteotomy

    Procedure: Iliac crest autograft

Interventions

  • ProcedureIliac crest allograft

    Opening wedge osteotomy of proximal tibia with allograft from iliac crest

  • ProcedureIliac crest autograft

    open wedge osteotomy of proximal tibia using autogenous iliac bone graft

06

What researchers measure

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

07

Study locations

1 site
  • Imam Khomeini Hospital
    Tehran, 1419173341, Iran, Islamic Republic of
08

References and documents

Publications

  • Haghpanah B, Kaseb MH, Espandar R, Mortazavi SMJ. No difference in union and recurrence rate between iliac crest autograft versus allograft following medial opening wedge high tibial osteotomy: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2021 Oct;29(10):3375-3381. doi: 10.1007/s00167-020-06240-w. Epub 2020 Aug 24. PubMed 32839849 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00595712
Lead sponsor
Tehran University of Medical Sciences
First posted
Jan 16, 2008
Start date
Sep 2007
Primary completion
Feb 2008
Completion
Feb 2010
Last update
May 25, 2010

Study contacts

Seyyed Mohammad J Mortazavi, M.D.
study director · Tehran University of Medical Sciences

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.

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