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

Lumbar Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00456378
• Other study ID #: DIAM™ Device vs. Cons. Care
• Status: Terminated
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Lumbar Degenerative Disc Disease

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