A Prospective, Randomized, Controlled Pivotal Clinical Investigation of DIAM™ Spinal Stabilization System in Patients With Degenerative Lumbar Spinal Stenosis.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Degenerative Lumbar Spinal Stenosis
- Sponsor
- Medtronic Spinal and Biologics
- Enrollment
- 32
- Primary Endpoint
- Rate of Overall Success
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this clinical trial is to evaluate the safety and effectiveness of the DIAM Spinal Stabilization System as a method of treating patients with symptoms of degenerative lumbar spinal stenosis at a single level from L2 to L5.
Detailed Description
This pivotal clinical trial is being conducted to evaluate the DIAM Spinal Stabilization System for the treatment of single-level degenerative lumbar spinal stenosis from L2 to L5. The implant under investigation in this clinical trial is the DIAM Spinal Stabilization System. And following a decompression procedure, the device will be implanted using a posterior surgical approach. Patients in the control group will receive a lumbar decompression.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Has a symptom complex consisting of back, buttock, or groin pain (excluding symptomatic coxarthrosis) with leg pain typical of intermittent neurogenic claudication, which is defined as leg(usually calf) discomfort, pain, numbness, paresthesias, weakness, or fatigue aggravated by standing or walking and is only relieved with resting in flexed lumbar spine position
- •Leg pain score ≥ 8 and back pain score ≥ 6 based on the Preop Back/ Leg Pain CRF.
- •Leg pain score must be ≥ back pain score
- •Narrowing of the lumbar spinal canal and/or intervertebral foramen at L2-L3, L3-L4, L4-L5 as indicated by MRI, with other MRI findings typical of spinal stenosis, such as trefoil canal shape; hypertrophy, thickening, buckling, or infolding of the ligamentum flavum; hypertrophied facet joints or facet joint capsule; annular bulging; or lateral (subarticular) stenosis.
- •Must sit for at least 30 min without severe pain
- •Must walk at least 100 ft unassisted
- •35 yrs of age, inclusive
- •Preoperative Oswestry score ≥ 40
- •Child-bearing potential, pt is not pregnant or nursing and agrees not to become pregnant during study period
- •Treated non-operatively for a pd of at least 6 mos
Exclusion Criteria
- •Disease state which requires destabilizing decompression
- •Axial back pain with no pain in leg, buttock, or groin
- •Baseline strength grade of 0 (total paralysis), 1 (palpable or visible contraction), or 2 (active movement, gravity,eliminated) in any lower extremity motor group as noted on Neuro Status CRF
- •Segmental kyphosis \>0° at indicated level
- •Cauda equina syndrome
- •Compression of nerve roots that causes neurogenic bowel, bladder dysfunction
- •Prior surgical procedure at involved or adjacent levels
- •Diagnosed with significant peripheral neuropathy
- •Significant vascular disease causing vascular claudication
- •Requires tx of spinal stenosis at more than 1 lumbar level
Outcomes
Primary Outcomes
Rate of Overall Success
Time Frame: 24 months after operation
Rate of overall success is reported as the percentage of partipants who met all of the following criteria: 1. Pain/disability (ODI) success:(Success of ODI is defined as pain/disability improvement according to the definition: Pre-treatment Score - Post-treatment Score ≥ 15); 2. Neurological success (Neurological success is defined as maintenance or improvement in sections of motor, sensory, reflex, and straight leg raise for the time period evaluated); 3. No serious adverse event classified as "surgical treatment associated"; 4. No additional surgical procedure classified as "failure."
Secondary Outcomes
- Success Rate of Oswestry Diability Index Scores(24 month after operation)
- Oswestry Disability Index (ODI) Score(24 month after operation)
- Back Pain(24 month after operation)
- Leg Pain Success Rate(24 month after operation)
- Leg Pain(24 month after operation)
- General Health Status (SF-36)(24 month after operation)
- Blood Loss(At the time of operation)
- Hospital Stay(At the time of discharge)
- Success Rate of Neurological Status(24 month after operation)
- Back Pain Success Rate(24 month after operation)
- Operative Time(at the time of operation)
- Success Rate of SF-36 Health Survey(24 month after operation)