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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00456378
Other study ID # DIAM™ Device vs. Cons. Care
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date December 2006
Est. completion date November 20, 2018

Study information

Verified date December 2018
Source Medtronic Spinal and Biologics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 311
Est. completion date November 20, 2018
Est. primary completion date October 8, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

Each patient participating in this clinical trial must meet all of the following inclusion criteria:

1. 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.

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:

A patient meeting any of the following criteria is to be excluded from this clinical trial:

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.

Study Design


Intervention

Device:
DIAM™ Spinal Stabilization System
Surgical procedure with implantation of the Investigational device
Procedure:
Conservative care
Six months of conservative care, to include: patient education, medications, physical therapy and spinal injections.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Medtronic Spinal and Biologics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Success A patient will be considered an overall success if all of the following conditions are met:
Pain/disability (Oswestry) success;
No serious adverse event classified as "implant associated", "implant-/surgical procedure associated", or "nonoperative treatment associated"; and
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 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
12 months
Secondary 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. 12 months
Secondary 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 12 months
Secondary 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
12 months
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