Study of the Safety and Effectiveness of DIAM™ Spinal Stabilization System Versus Conservative Care
NCT ID: NCT00456378
Last Updated: 2018-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
311 participants
INTERVENTIONAL
2006-12-31
2018-11-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DIAM™ spinal stabilization system
Implantation of the DIAM Spinal Stabilization System
DIAM™ Spinal Stabilization System
Surgical procedure with implantation of the Investigational device
Conservative care
Conservative Care
Conservative care
Six months of conservative care, to include: patient education, medications, physical therapy and spinal injections.
Interventions
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DIAM™ Spinal Stabilization System
Surgical procedure with implantation of the Investigational device
Conservative care
Six months of conservative care, to include: patient education, medications, physical therapy and spinal injections.
Eligibility Criteria
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Inclusion Criteria
* 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.
2. Is 18-70 years of age, inclusive, and is skeletally mature.
3. Has pre-treatment Oswestry score ≥ 30.
4. Has pre-treatment back pain score of ≥ 8 based on the Pre-Treatment Back and Leg Pain Questionnaire (Back Pain Intensity + Back Pain Frequency).
5. 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.
6. If of child-bearing potential, patient is not pregnant or nursing and agrees not to become pregnant during the study period.
7. 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.
8. Is willing and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form.
Exclusion Criteria
1. Has disc height loss \> 67% at the involved level, compared to the next adjacent (superior or inferior, whichever has greater disc height) spinal level
2. Has Arachnoiditis.
3. Has a primary diagnosis of a spinal disorder other than degenerative disc disease at the involved level.
4. Requires treatment of degenerative disc disease at more than one lumbar level.
5. Has had all of the following nonoperative treatments (prescribed medications, active physical therapy, spinal injections, and patient education) within the past 6 weeks.
6. Has a sequestered herniated nucleus pulposus.
7. Has had any previous surgery at the involved or adjacent spinal levels (including procedures such as rhizotomy).
8. Has received any intradiskal ablation therapy, such as IDET.
9. Has congenital or iatrogenic posterior element insufficiency (e.g. facet resection, spondylolysis, pars fracture, or Spinal Bifida Occulta).
10. Has back pain (with or without leg, buttock, or groin pain) that is not alleviated in any spinal position.
11. Has a motor deficit of the lower extremity.
12. Has cauda equina syndrome.
13. Has compression of nerve roots with neurogenic bowel (fecal incontinence) or bladder (urinary retention or incontinence) dysfunction.
14. Has been previously diagnosed with clinically significant peripheral neuropathy.
15. Has significant vascular disease causing vascular claudication.
16. 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).
17. Has ventral spondylolisthesis with more than 2 mm of translation at the involved level.
18. Has evidence of prior fracture or trauma to the L1, L2, L3, L4, or L5 levels in either compression or burst.
19. Has lumbar scoliosis with a Cobb angle of greater than 15°.
20. Has lumbar kyphosis or flat back syndrome.
21. Has sustained a hip fracture within the last year.
22. 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.):
1. Previous diagnosis of osteoporosis, osteopenia, or osteomalacia.
2. Postmenopausal Non-Black female over 60 years of age who weighs less than 140 pounds.
3. Postmenopausal female who has sustained a non-traumatic hip, spine or wrist fracture.
4. Male over the age of 60 who has sustained a non-traumatic hip or spine fracture.
If the level of DEXA T-score is -1.0 or lower (i.e., -1.5, -2.0, etc.), the patient is excluded from the study.
23. Has obesity defined by BMI greater than or equal to 40. (Refer to the BMI Table provided in the CIP.)
24. Has a documented allergy to silicone, polyethylene, titanium, or latex.
25. Has overt or active bacterial infection, either local or systemic, and/or potential for bacteremia.
26. Has a suppressed immune system or has taken steroids at any dose daily for more than one month within the last year (excluding low dose inhalers for the treatment of asthma).
27. Has a history of autoimmune disease.
28. Has presence of active malignancy or prior history of malignancy within the last 5 years (except for basal cell carcinoma of the skin).
29. Has presence or prior history of a spinal malignancy.
30. Has chronic or acute renal and/or hepatic failure or prior history of renal and/or hepatic parenchymal disease.
31. Has any disease (e.g., neuromuscular disease) that would preclude accurate clinical evaluation of the safety and effectiveness of the treatment regimens in this study.
32. Has received treatment with an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 24 months following enrollment in the study.
33. Has an implantable metal device (e.g., stimulator, pacemaker) and is unable to have an MRI.
34. Is an alcohol and/or drug abuser, as defined by currently undergoing treatment for alcohol and/or drug abuse.
35. Is mentally incompetent. If questionable, obtain psychiatric consult.
36. Has a Waddell Signs of Inorganic Behavior score of 3 or greater.
37. Is a prisoner.
18 Years
70 Years
ALL
No
Sponsors
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Medtronic Spinal and Biologics
INDUSTRY
Responsible Party
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Locations
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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
Neurospine Surgical Consultants
Plano, Texas, United States
Spine Team Texas
Southlake, Texas, United States
The Smart Clinic
Sandy City, Utah, United States
Department of Neurosurgery, University of Virginia Health System
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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DIAM™ Device vs. Cons. Care
Identifier Type: -
Identifier Source: org_study_id