A Prospective, Randomized, Controlled Pivotal Clinical Investigation of DIAM™ Spinal Stabilization System in Patients With Lumbar Degenerative Disc Disease.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lumbar Degenerative Disc Disease
- Sponsor
- Medtronic Spinal and Biologics
- Enrollment
- 311
- Locations
- 29
- Primary Endpoint
- Overall Success
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to establish the safety and effectiveness of the DIAM™ Spinal Stabilization System in the treatment of moderate single-level lumbar degenerative disc disease.
Detailed Description
This pivotal clinical trial is being conducted to evaluate the DIAM™ Spinal Stabilization System for the treatment of single-level moderate lumbar degenerative disc disease. The implant under investigation in this clinical trial is the DIAM Spinal Stabilization System, and the device will be implanted using a posterior surgical approach. Patients in the control group will receive nonoperative treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Each patient participating in this clinical trial must meet all of the following inclusion criteria:
- •Has moderate low back pain secondary to lumbar degenerative disc disease at a single level from L2 - L
- •Low back pain is defined as persistent back pain, with or without radicular pain, with current episode of less than one year duration. Degenerative disc disease is confirmed by patient history, physical examination, and radiographic studies with one or more of the following factors (as measured radiographically by MRI scans or x-rays):
- •Decreased disc height \>2mm, compared to the disc space at the next adjacent (superior or inferior, whichever has greater disc height) spinal level;
- •Scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule;
- •Herniated nucleus pulposus.
- •Is 18-70 years of age, inclusive, and is skeletally mature.
- •Has pre-treatment Oswestry score ≥
- •Has pre-treatment back pain score of ≥ 8 based on the Pre-Treatment Back and Leg Pain Questionnaire (Back Pain Intensity + Back Pain Frequency).
- •Has been treated nonoperatively (e.g. bed rest, physical therapy, medications, TENS, manipulation, and/or spinal injections) for a period of at least 6 weeks and not more than 6 months prior to enrollment in the clinical study.
Exclusion Criteria
- •A patient meeting any of the following criteria is to be excluded from this clinical trial:
- •Has disc height loss \> 67% at the involved level, compared to the next adjacent (superior or inferior, whichever has greater disc height) spinal level
- •Has Arachnoiditis.
- •Has a primary diagnosis of a spinal disorder other than degenerative disc disease at the involved level.
- •Requires treatment of degenerative disc disease at more than one lumbar level.
- •Has had all of the following nonoperative treatments (prescribed medications, active physical therapy, spinal injections, and patient education) within the past 6 weeks.
- •Has a sequestered herniated nucleus pulposus.
- •Has had any previous surgery at the involved or adjacent spinal levels (including procedures such as rhizotomy).
- •Has received any intradiskal ablation therapy, such as IDET.
- •Has congenital or iatrogenic posterior element insufficiency (e.g. facet resection, spondylolysis, pars fracture, or Spinal Bifida Occulta).
Outcomes
Primary Outcomes
Overall Success
Time Frame: 12 months
A patient will be considered an overall success if all of the following conditions are met: 1. Pain/disability (Oswestry) success; 2. No serious adverse event classified as "implant associated", "implant-/surgical procedure associated", or "nonoperative treatment associated"; and 3. For patients in the investigational group, no additional surgical procedure at the involved level classified as a failure. For patients in the control group, no "treatment surgery" at the involved level that was the result of a poor response to conservative care treatment.
Secondary Outcomes
- Pain/Disability Status(12 months)
- Neurological Status(12 months)
- Pain Status (Back Pain and Leg Pain)(12 months)
- General Health Status(12 months)