DIAM™ Spinal Stabilization System vs. Decompression, Formerly vs. Posterolateral Fusion

Stopped early · Phase 3

Conditions studied: Degenerative Lumbar Spinal Stenosis

In brief

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.

Key facts

Study ID

NCT00627497

Run by

Medtronic Spinal and Biologics

People needed

32

Starts

2008-02-01

Expected to finish

2010-12-01

Last updated by the study team

2021-01-05

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Willing and able to comply with study plan and able to understand and sign Pt ICF

You may not qualify if…

• 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
• Significant lumbar instability, defined as > 3mm translation on flexion/extension radiographs
• Has > 3mm fixed spondylolisthesis at affected level
• BMI ≥ 40
• Sustained vertebral or hip fracture within last year
• Has the following (if "Yes" to any risk below, a lumbar spine DEXA Scan is required for eligibility)
• Previous diagnosis of osteoporosis, osteopenia, or osteomalacia
• Postmenopausal Non-Black female over age of 60 who weighs ≤ 140 lbs
• Postmenopausal female who has sustained a non traumatic hip, spine or wrist fracture
• Male over age of 60 who has sustained non-traumatic hip or spine fracture
• If level of DEXA T-score is -1.0 or lower pt is excluded from study
• Lumbar scoliosis with Cobb angle of > 15°
• Documented allergy to silicone, polyethylene, titanium or latex
• Overt or active bacterial infection, local, systemic, and/or potential for bacteremia
• Alcohol and/or drug abuser
• Received tx with investigational therapy (device and/or pharmaceutical) within 30 days prior to entering study or such tx is planned during the 24 mos following enrollment in study

Where it is running

• Study site — Fremont, California, United States
• Study site — Jacksonville, Florida, United States
• Study site — Melbourne, Florida, United States
• Study site — Temple Terrace, Florida, United States
• Study site — Columbus, Georgia, United States
• Study site — Baton Rouge, Louisiana, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Chattanooga, Tennessee, United States

Full record on ClinicalTrials.gov

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