Evaluation of Fusion After Anterior Lumbar Interbody Fusion With a New Osteoinductive Bone Substitute Material: a First Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fusion of Spine, Lumbar Region
- Sponsor
- Johann Wolfgang Goethe University Hospital
- Enrollment
- 20
- Primary Endpoint
- Oswestry Disability Index (ODI)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The aim of this study was to determine whether instrumented anterior lumbar interbody Fusion with a new nanocrystalline hydroxyapatite embedded in a silica gel matrix (NH-SiO2) was associated with superior radiological and clinical outcomes at 12 months follow-up compared with instrumented ALIF with homologous bone
Detailed Description
This randomized clinical trial included two groups of 20 mature patients with mono- or multisegmental degenerative disease of the lumbar spine who were suitable to undergo mono- or bisegmental ALIF fusion at the level L4/L5 and L5/S1 with a carbon fiber reinforced polymer ALIF cage filled with either NH-SiO2 or homologous bone (HB). Patients were followed 12 months postoperatively. The primary aim was to compare postoperative disability as measured by the Oswestry Disability Index (ODI). Secondary aims were to compare postoperative radiographic outcomes and differences in pain and quality of life between these groups.
Investigators
Mohammad ARAB MOTLAGH
MD, PhD
Johann Wolfgang Goethe University Hospital
Eligibility Criteria
Inclusion Criteria
- •chronic low back pain
- •sensorimotor deficits
- •radiculopathy and spinal claudication symptoms, all caused by degenerative changes in the lumbar spine, which were resistant to conservative pain therapy and / or physiotherapy
Exclusion Criteria
- •previous surgeries in the abdominal Region
- •previous fusion surgery in the lumbar spine.
Outcomes
Primary Outcomes
Oswestry Disability Index (ODI)
Time Frame: 12 months after surgery
Postoperative disability as measured by the Oswestry Disability Index (ODI)
Secondary Outcomes
- Fusion rate(12 months after surgery)