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

Tehran University of Medical Sciences

Status and phase: Completed; Phase 3

Conditions: Genovarum

Treatments: Procedure: Iliac crest autograft; Procedure: Iliac crest allograft

Study type: Interventional

Funder types: Other

Identifiers

NCT00595712

86-09-30-4111

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

A

Active Comparator group

Description:

Using Iliac crest allograft in high tibial osteotomy

Treatment:

Procedure: Iliac crest allograft

B

Active Comparator group

Description:

Using iliac crest autograft in high tibial osteotomy

Treatment:

Procedure: Iliac crest autograft