Clinical Study to Evaluate the Safety and Effectiveness of the Aesculap Activ-L™ Artificial Disc in the Treatment of Degenerative Disc Disease
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Degenerative Disc Disease
- Sponsor
- Aesculap Implant Systems
- Enrollment
- 376
- Locations
- 17
- Primary Endpoint
- Absence of Serious Device Related Adverse Events
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to learn whether an investigational device called the Activ-L Artificial Disc is safe and effective in the treatment of degenerative disc disease of the lower (lumbar) spine.
Detailed Description
The objective of this clinical study is to evaluate the safety and effectiveness of the Activ-L Artificial Disc for treatment of single-level degenerative disc disease of the lumbar spine in patients who have been unresponsive to at least six months of prior conservative care. The hypothesis of the study is that the Activ-L Disc is non-inferior to the control (the Charité® Artificial Disc \[DePuy Spine\] or ProDisc-L® Total Disc Replacement \[Synthes Spine\]) with respect to the rate of individual subject success at 24 months. Individual subject success is a composite of effectiveness and safety.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 - 60, skeletally mature
- •Symptomatic DDD with objective evidence of lumbar DDD, with any of the following characteristics by MRI scan:
- •instability as defined by ≥ 3mm translation or ≥ 5° angulation.
- •osteophyte formation of facet joints or vertebral endplates.
- •decreased disc height of \>2mm as compared to the adjacent level.
- •scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule.
- •herniated nucleus pulposus.
- •facet joint degeneration/changes.
- •vacuum phenomenon.
- •Single level symptomatic disease at L4/L5 or L5/S
Exclusion Criteria
- •Previous surgery at any lumbar level, except IDET (Intradiscal Electrothermal Annuloplasty), percutaneous nucleoplasty, or microdiscectomy.
- •Chronic radiculopathy, i.e., subject complaint of unremitting pain with a predominance of leg pain symptoms greater than back pain symptoms extending over a period of at least 1 year.
- •endplate dimensions smaller than 34.5 mm in medial-lateral and/or 27 mm in the anterior-posterior direction
- •Evidence of significant, symptomatic disc degeneration at another lumbar level.
- •Preoperative remaining disc height \< 3mm
- •Myelopathy.
- •Previous compression or burst fracture at the affected level.
- •Sequestered herniated nucleus pulposus with migration.
- •Mid-sagittal stenosis of \<8mm (by MRI).
- •Degenerative or lytic spondylolisthesis \> 3mm.
Outcomes
Primary Outcomes
Absence of Serious Device Related Adverse Events
Time Frame: 24 months
Percent of subjects demonstrating no device related SAE's at 24 months as per the Clinical Events Committee (CEC)
Overall Success at 24 Months Relative to Baseline
Time Frame: 24 months
Measured by absence of treatment failure; absence or serious device related AE; maintenance or improvement of ROM at index level; maintenance or improvement of neurological status; improvement in ODI score.
Range of Motion (ROM) Success
Time Frame: 24 months
Percent of subjects demonstrating maintenance or improvement in ROM at 24 months compared to baseline
Neurological Success
Time Frame: 24 months
Percent of patients demonstrating maintenance or improvement in combined motor and sensory evaluations at 24 months compared to baseline
Device Success
Time Frame: 24 months
Percent of subjects demonstrating no Subsequent Surgical Interventions (SSI's) at the index level (L4-L5 or L5-S1) at 24 months.
ODI Success
Time Frame: 24 months
Percent of subjects demonstrating an improvement of greater than or equal to 15 points at 24 months compared to baseline
Secondary Outcomes
- VAS Success for Back and Leg Pain at Rest(24 months)
- ODI Success Using Two Measures of Success(24 months)
- Improvement in SF-36 Scores(24 months)