RecruitingACTRN12609000548235

A prospective, randomised study comparing the use of Actifuse (trademark) Advanced Bone MatriX (ABX) synthetic bone substitute with INFUSE (registered trademark) in patients requiring posterolateral instrumented lumbar fusion.

A prospective, randomised study comparing the use of Actifuse (trademark) Advanced Bone MatriX (ABX) synthetic bone substitute with INFUSE (registered trademark) on fusion in patients requiring posterolateral instrumented lumbar fusion.


Sponsor

ApaTech Ltd

Enrollment

100 participants

Start Date

Jul 6, 2009

Study Type

Interventional

Conditions


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two materials used in a type of lower back surgery called posterolateral lumbar fusion. When the discs in your lower back break down, they can cause back and leg pain. In some cases, surgery is needed to fuse the vertebrae (spine bones) together. During this procedure, a bone-like substance is placed to help the bones knit together. This trial tests whether a synthetic substitute called Actifuse ABX works as well as a product called INFUSE (which contains a bone-stimulating protein). You may be eligible if: - You have degenerative disc disease of the lower back causing back or leg pain - Your imaging (X-ray, CT, or MRI) shows signs of disc or spinal joint damage - Your Oswestry Back Disability Score is 30 or more - You are between 18 and 80 years old You may NOT be eligible if: - You have had a previous failed spinal fusion at the same level - You have a spinal infection, tumor, or trauma - You need surgery at more than two spinal levels - You have osteoporosis - You are pregnant Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Posterolateral Intertransverse Process Fusion and Internal Fixation achieved by pedicle screws and rods and bone graft substitute (Actifuse ABX) with the bone graft laid on between the decorticated tr

Posterolateral Intertransverse Process Fusion and Internal Fixation achieved by pedicle screws and rods and bone graft substitute (Actifuse ABX) with the bone graft laid on between the decorticated transverse processes of the spine.


Locations(1)

Australia

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ACTRN12609000548235