A Multi-Center Prospective Randomized Study to Evaluate the Efficacy of the Aspen Spinous Process System for Use in Anterior Lumbar Interbody Fusion (ALIF)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Degenerative Disc Disease
- Sponsor
- Zimmer Biomet
- Locations
- 5
- Primary Endpoint
- Oswestry Disability Index (ODI)
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
Brief Summary
This is a multi-center, prospective randomized clinical study to evaluate the clinical outcome of subjects with degenerative disc disease (DDD) treated with ALIF and supplemental posterior fixation using ASPEN Spinous Process System compared to pedicle screw instrumentation.
Detailed Description
This is a multi-center, prospective randomized clinical study to evaluate the clinical outcome of subjects with DDD who are treated with ALIF and supplemental posterior fixation using Aspen compared to pedicle screw instrumentation. The study will involve up to approximately 25 investigational sites and enroll up to 156 67 subjects. The randomization ratio of two Aspen subjects to one pedicle screw subject (2:1) will be utilized. Subjects with lumbar DDD who are candidates for ALIF at a single level will be screened for inclusion in the study. If the subject meets all of the eligibility criteria, they will be enrolled and randomized to either the Aspen or pedicle screw group. Subjects will continue to be followed by the guidelines set forth in this clinical protocol, which include: a postoperative discharge exam; six week, three month, six month, and one year post-op visits; and, concludes with a two year post-op visit. The follow-up is counted from the day of surgery. The enrollment period is expected to be approximately 12 months and subjects will be followed for 2 years post-op for the duration of the clinical investigation. The anticipated duration of the study is approximated to be 3 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age between 18 and 75 years
- •Scheduled for an elective single level ALIF with posterior fixation
- •Diagnosis of primary symptomatic DDD confirmed with appropriate imaging studies and/or positive lumbar discography
- •Oswestry Disability Index (ODI) v 2.1 score \>30%
- •Failed at least 6 weeks of conservative care (non-surgical)/clinical signs of neurological deterioration
- •No contraindications for ASPEN spinous process system (at the discretion of the investigator)
Exclusion Criteria
- •Prior lumbar fusion surgery at any level (prior discectomy and/or laminectomy allowed)
- •Spondylolisthesis grade 3 or more
- •Lytic spondylolisthesis
- •Incompetent or missing posterior arch at the affected level (e.g. laminectomy, pars defect)
- •Currently requires laminectomy at level of surgery
- •Facet joints at implant level are absent or fractured
- •Post-traumatic vertebral body compromise or acute fracture at implant level
- •Body mass Index (BMI) \> 40
- •Known allergy to titanium
- •Osteoporosis: SCORE (Simple Calculated Osteoporosis Risk Estimation) will be used to screen subjects who require DEXA. Subjects with T-score \< -2.5 will be excluded
Outcomes
Primary Outcomes
Oswestry Disability Index (ODI)
Time Frame: 2 years