RecruitingACTRN12609000527268

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 with interbody fusion

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


Sponsor

ApaTech Ltd

Enrollment

100 participants

Start Date

Jun 27, 2007

Study Type

Interventional

Conditions


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing two different bone graft materials used during a type of spine surgery called lumbar fusion with interbody fusion. When the discs in your lower back wear down and cause back or leg pain, surgery is sometimes needed to fuse the vertebrae together. During this surgery, a bone-like material is placed to help the bones grow together. This trial compares a synthetic bone substitute called Actifuse ABX with a product called INFUSE to see which works better. You may be eligible if: - You have degenerative disc disease of the lower back causing back pain, with or without leg pain - Your imaging scans (X-ray, CT, or MRI) show changes in your spine such as disc height loss, canal narrowing, or joint changes - Your Oswestry Back Disability Score is 30 or higher (indicating significant disability) - You are between 18 and 75 years old You may NOT be eligible if: - You have previously had a failed fusion surgery at the same level - You have a spinal infection, tumor, or spinal trauma - You need surgery at more than two spinal levels - You have osteoporosis (not just osteopenia) - 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

Posterior Lumbar Interbody Fusion with Posterolateral Intertransverse Process Fusion and Internal Fixation achieved by pedicle screws and rods and bone graft substitute (Actifuse ABX), with the bone g

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


Locations(1)

Netherlands

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ACTRN12609000527268