Study of the Safety and Effectiveness of DIAM™ Spinal Stabilization System Versus Conservative Care

Stopped early · Not applicable

Conditions studied: Lumbar Degenerative Disc Disease

In brief

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.

Key facts

Study ID: NCT00456378
Run by: Medtronic Spinal and Biologics
People needed: 311
Starts: 2006-12-01
Expected to finish: 2018-11-20
Last updated by the study team: 2018-12-10

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 - L5. 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 ≥ 30.
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.
If of child-bearing potential, patient is not pregnant or nursing and agrees not to become pregnant during the study period.
Is willing and able to participate in either of the randomized treatments for the duration of the study follow-up period. If the patient is randomized to the investigational group, he/she is willing to undergo surgery and receive the DIAM device. If the patient is randomized to the control group, he/she is willing to undergo all four nonoperative treatments.
Is willing and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form.

You may not qualify if…

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).
Has back pain (with or without leg, buttock, or groin pain) that is not alleviated in any spinal position.
Has a motor deficit of the lower extremity.
Has cauda equina syndrome.
Has compression of nerve roots with neurogenic bowel (fecal incontinence) or bladder (urinary retention or incontinence) dysfunction.
Has been previously diagnosed with clinically significant peripheral neuropathy.
Has significant vascular disease causing vascular claudication.
Has a medical contraindication that prevents the patient from receiving spinal injections (i.e., allergy to contrast media used to aid in placement of the needle in the epidural space).
Has ventral spondylolisthesis with more than 2 mm of translation at the involved level.
Has evidence of prior fracture or trauma to the L1, L2, L3, L4, or L5 levels in either compression or burst.
Has lumbar scoliosis with a Cobb angle of greater than 15°.
Has lumbar kyphosis or flat back syndrome.
Has sustained a hip fracture within the last year.
Has any of the following (if "Yes" to any of the below risk factors, a lumbar spine DEXA Scan will be required to determine eligibility.):
Previous diagnosis of osteoporosis, osteopenia, or osteomalacia.
Postmenopausal Non-Black female over 60 years of age who weighs less than 140 pounds.

Where it is running

Spine Institute of Arizona — Scottsdale, Arizona, United States
Tower Orthopaedic & Neurosurgical Spine Institute — Beverly Hills, California, United States
Los Angeles Brain and Spine Institute — Los Angeles, California, United States
Neurological Surgery — Mission Viejo, California, United States
Loma Linda Orthopaedic Dept — San Bernardino, California, United States
Boulder Neurosurgical Associates — Boulder, Colorado, United States
George Washington University Medical Faculty Associates — Washington D.C., District of Columbia, United States
Tallahassee Neurological Clinic — Tallahassee, Florida, United States
Foundation for Orthopaedic Research and Education (FORE) — Tampa, Florida, United States
Georgia Neurological Surgery — Athens, Georgia, United States
Dr. Sokolowski — Oak Park, Illinois, United States
Indiana Spine Group — Carmel, Indiana, United States
Fort Wayne Orthopaedics — Fort Wayne, Indiana, United States
OrthoIndy — Indianapolis, Indiana, United States
Precision Spine and Orthopaedic Specialists — Overland Park, Kansas, United States
Kansas Joint & Spine Institute — Wichita, Kansas, United States
Sports Medicine North Orthopaedic Surgery, Inc. — Peabody, Massachusetts, United States
University Physicians Group — Detroit, Michigan, United States
Twin Cities Spine Center — Minneapolis, Minnesota, United States
The Orthopedic Center of St. Louis — Chesterfield, Missouri, United States
Advanced Neurosurgery Inc. / Kettering Medical Center — Kettering, Ohio, United States
NeuroSpine Institute — Eugene, Oregon, United States
Argires, Becker, Marotti, & Westphal Brain, Orthopedic/Sports Medicine & Spine Care — Lancaster, Pennsylvania, United States
Orthopedic Institute — Sioux Falls, South Dakota, United States
Spine Specialty Center — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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