Results of Opening-wedge High Tibial Osteotomy Using Iliac Crest Allograft Compared to Iliac Crest Autograft
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 5, 2008
CompletedFirst Posted
Study publicly available on registry
January 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedMay 25, 2010
May 1, 2010
5 months
January 5, 2008
May 22, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Range of motion of the knee
before op and at follow ups
knee score (womac)
before op and at final follow up
Study Arms (2)
A
ACTIVE COMPARATORUsing Iliac crest allograft in high tibial osteotomy
B
ACTIVE COMPARATORUsing iliac crest autograft in high tibial osteotomy
Interventions
Opening wedge osteotomy of proximal tibia with allograft from iliac crest
open wedge osteotomy of proximal tibia using autogenous iliac bone graft
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Imam Khomeini Hospital
Tehran, 1419173341, Iran
Related Publications (1)
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.
PMID: 32839849DERIVED
Study Officials
- STUDY DIRECTOR
Seyyed Mohammad J Mortazavi, M.D.
Tehran University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 5, 2008
First Posted
January 16, 2008
Study Start
September 1, 2007
Primary Completion
February 1, 2008
Study Completion
February 1, 2010
Last Updated
May 25, 2010
Record last verified: 2010-05