Study Stopped
Business decision, no safety concerns
Study of the Safety and Effectiveness of DIAM™ Spinal Stabilization System Versus Conservative Care
A Prospective, Randomized, Controlled Pivotal Clinical Investigation of DIAM™ Spinal Stabilization System in Patients With Lumbar Degenerative Disc Disease.
1 other identifier
interventional
311
1 country
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2006
Longer than P75 for not_applicable
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 29, 2007
CompletedFirst Posted
Study publicly available on registry
April 4, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 8, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2018
CompletedDecember 10, 2018
December 1, 2018
8.9 years
March 29, 2007
December 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Success
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.
12 months
Secondary Outcomes (4)
Pain/Disability Status
12 months
Neurological Status
12 months
Pain Status (Back Pain and Leg Pain)
12 months
General Health Status
12 months
Study Arms (2)
DIAM™ spinal stabilization system
EXPERIMENTALImplantation of the DIAM Spinal Stabilization System
Conservative care
ACTIVE COMPARATORConservative Care
Interventions
Surgical procedure with implantation of the Investigational device
Six months of conservative care, to include: patient education, medications, physical therapy and spinal injections.
Eligibility Criteria
You may qualify if:
- 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.
- +28 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Spine Institute of Arizona
Scottsdale, Arizona, United States
Tower Orthopaedic & Neurosurgical Spine Institute
Beverly Hills, California, 90211, United States
Los Angeles Brain and Spine Institute
Los Angeles, California, 90036, United States
Neurological Surgery
Mission Viejo, California, 92691, United States
Loma Linda Orthopaedic Dept
San Bernardino, California, 92408, United States
Boulder Neurosurgical Associates
Boulder, Colorado, 80304, United States
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
Tallahassee Neurological Clinic
Tallahassee, Florida, 32308, United States
Foundation for Orthopaedic Research and Education (FORE)
Tampa, Florida, 33637, United States
Georgia Neurological Surgery
Athens, Georgia, 30606, United States
Dr. Sokolowski
Oak Park, Illinois, 60302, United States
Indiana Spine Group
Carmel, Indiana, 46032, United States
Fort Wayne Orthopaedics
Fort Wayne, Indiana, 46804, United States
OrthoIndy
Indianapolis, Indiana, 46260, 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, 01960, United States
University Physicians Group
Detroit, Michigan, 48201, United States
Twin Cities Spine Center
Minneapolis, Minnesota, 55404, United States
The Orthopedic Center of St. Louis
Chesterfield, Missouri, 63017, United States
Advanced Neurosurgery Inc. / Kettering Medical Center
Kettering, Ohio, 45429, United States
NeuroSpine Institute
Eugene, Oregon, 97401, United States
Argires, Becker, Marotti, & Westphal Brain, Orthopedic/Sports Medicine & Spine Care
Lancaster, Pennsylvania, 17601, United States
Orthopedic Institute
Sioux Falls, South Dakota, 57105, United States
Spine Specialty Center
Memphis, Tennessee, 38119, United States
Neurospine Surgical Consultants
Plano, Texas, United States
Spine Team Texas
Southlake, Texas, United States
The Smart Clinic
Sandy City, Utah, 84070, United States
Department of Neurosurgery, University of Virginia Health System
Charlottesville, Virginia, 22908, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2007
First Posted
April 4, 2007
Study Start
December 1, 2006
Primary Completion
October 8, 2015
Study Completion
November 20, 2018
Last Updated
December 10, 2018
Record last verified: 2018-12