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Lumbar Degenerative Disc DiseaseNCT00456378

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

A study testing DIAM™ Spinal Stabilization System and Conservative care in people with Lumbar Degenerative Disc Disease, run by Medtronic Spinal and Biologics at 29 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Lumbar Degenerative Disc Disease
What is being tested?
DIAM™ Spinal Stabilization System and Conservative care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
311 participants
Where
29 sitesUnited States
Study dates
Dec 2006to 20 Nov 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Postmenopausal female who has sustained a non-traumatic hip, spine or wrist fracture.
  • 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.
  • Has obesity defined by BMI greater than or equal to 40. (Refer to the BMI Table provided in the CIP.)
  • Has a documented allergy to silicone, polyethylene, titanium, or latex.
  • Has overt or active bacterial infection, either local or systemic, and/or potential for bacteremia.
  • 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).
  • Has a history of autoimmune disease.
  • Has presence of active malignancy or prior history of malignancy within the last 5 years (except for basal cell carcinoma of the skin).
  • Has presence or prior history of a spinal malignancy.
  • Has chronic or acute renal and/or hepatic failure or prior history of renal and/or hepatic parenchymal disease.
  • 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.
  • 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.
  • Has an implantable metal device (e.g., stimulator, pacemaker) and is unable to have an MRI.
  • Is an alcohol and/or drug abuser, as defined by currently undergoing treatment for alcohol and/or drug abuse.
  • Is mentally incompetent. If questionable, obtain psychiatric consult.
  • Has a Waddell Signs of Inorganic Behavior score of 3 or greater.
  • Is a prisoner.

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

United States29 sites

  • Georgia Neurological Surgery

    Athens, Georgia, 30606

  • Tower Orthopaedic & Neurosurgical Spine Institute

    Beverly Hills, California, 90211

  • Boulder Neurosurgical Associates

    Boulder, Colorado, 80304

  • Indiana Spine Group

    Carmel, Indiana, 46032

  • Department of Neurosurgery, University of Virginia Health System

    Charlottesville, Virginia, 22908

  • The Orthopedic Center of St. Louis

    Chesterfield, Missouri, 63017

  • University Physicians Group

    Detroit, Michigan, 48201

  • NeuroSpine Institute

    Eugene, Oregon, 97401

  • Fort Wayne Orthopaedics

    Fort Wayne, Indiana, 46804

  • OrthoIndy

    Indianapolis, Indiana, 46260

  • Advanced Neurosurgery Inc. / Kettering Medical Center

    Kettering, Ohio, 45429

  • Argires, Becker, Marotti, & Westphal Brain, Orthopedic/Sports Medicine & Spine Care

    Lancaster, Pennsylvania, 17601

  • Los Angeles Brain and Spine Institute

    Los Angeles, California, 90036

  • Spine Specialty Center

    Memphis, Tennessee, 38119

  • Twin Cities Spine Center

    Minneapolis, Minnesota, 55404

  • Neurological Surgery

    Mission Viejo, California, 92691

  • Dr. Sokolowski

    Oak Park, Illinois, 60302

  • Precision Spine and Orthopaedic Specialists

    Overland Park, Kansas

  • Sports Medicine North Orthopaedic Surgery, Inc.

    Peabody, Massachusetts, 01960

  • Neurospine Surgical Consultants

    Plano, Texas

  • Loma Linda Orthopaedic Dept

    San Bernardino, California, 92408

  • The Smart Clinic

    Sandy City, Utah, 84070

  • Spine Institute of Arizona

    Scottsdale, Arizona

  • Orthopedic Institute

    Sioux Falls, South Dakota, 57105

  • Spine Team Texas

    Southlake, Texas

  • Tallahassee Neurological Clinic

    Tallahassee, Florida, 32308

  • Foundation for Orthopaedic Research and Education (FORE)

    Tampa, Florida, 33637

  • George Washington University Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

  • Kansas Joint & Spine Institute

    Wichita, Kansas

Other trials in United States

About this study

Official title: A Prospective, Randomized, Controlled Pivotal Clinical Investigation of DIAM™ Spinal Stabilization System in Patients With Lumbar Degenerative Disc Disease.

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.

Read the detailed description

This pivotal clinical trial is being conducted to evaluate the DIAM™ Spinal Stabilization System for the treatment of single-level moderate lumbar degenerative disc disease. The implant under investigation in this clinical trial is the DIAM Spinal Stabilization System, and the device will be implanted using a posterior surgical approach. Patients in the control group will receive nonoperative treatment.

Being tested
DIAM™ Spinal Stabilization System, Conservative care
Medical subject headings
Intervertebral Disc Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DIAM™ Spinal Stabilization SystemDevice

    Surgical procedure with implantation of the Investigational device

  • Conservative careProcedure or surgery

    Six months of conservative care, to include: patient education, medications, physical therapy and spinal injections.

Study groups in NCT00456378
Study groupRoleWhat they receive
DIAM™ spinal stabilization systemExperimentalImplantation of the DIAM Spinal Stabilization System
Receives: Device: DIAM™ Spinal Stabilization System
Conservative careActive comparatorConservative Care
Receives: Procedure: Conservative care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (4)

  1. Pain/Disability Status

    The self-administered Oswestry Low Back Pain Disability Questionnaire will be used. Success will be defined as pain/disability improvement according to the following definition:

    Pre-treatment Score - Post-treatment Score ≥ 15

    Measured: 12 months

  2. Neurological Status

    Neurological status is based on four types of measurements: motor, sensory, reflexes, and straight leg raising. Each of the sections is comprised of a number of elements. Overall neurological success will be defined as maintenance or improvement in all sections ( motor, sensory, reflex, and straightleg raising ) for the time period evaluated.

    Measured: 12 months

  3. Pain Status (Back Pain and Leg Pain)

    Numerical rating scales will be used to evaluate pain intensity and duration. The pain score (0 min, 20 Max) is derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be.") and duration scales (0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time"). Success for back pain and leg pain is described as follows: Pre-treatment Score - Post-treatment Score >0

    Measured: 12 months

  4. General Health Status

    The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) will be used to assess general health status. The SF-36 physical component summary (PCS) measures a patient's physical wellbeing and will be calculated according to algorithms formulated by the Medical Outcomes Trust. To be classified as a success, the following criterion must be met for SF-36 PCS:

    PCSPost-tx - PCSPre-tx >= 0

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2007 (estimated)
  2. Study startDec 2006
  3. Primary completion8 Oct 2015
  4. Study completion20 Nov 2018

Why it stopped: Business decision, no safety concerns

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
311 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00456378
Sponsor's protocol ID
DIAM™ Device vs. Cons. Care
Status last verified
Dec 2018
First submitted
29 Mar 2007
Last updated
10 Dec 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing DIAM™ Spinal Stabilization System and Conservative care in people with Lumbar Degenerative Disc Disease, run by Medtronic Spinal and Biologics at 29 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Business decision, no safety concerns). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Success (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00456378.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2018.

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