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PRODISC

Inclusion Criteria for Clinical Trials

“A multi-center, prospective, randomized, controlled clinical trial comparing the safety and effectiveness of PRODISC® total disc replacement to spinal fusion surgery in the treatment of discogenic pain associated with degenerative disc disease (DDD) in the lumbosacral spine."

The trade name of the study device is PRODISC®.

Objective

The objective of this clinical investigation is to compare the safety and effectiveness of PRODISC® total disc replacement to spinal fusion surgery in the treatment of discogenic pain associated with Degenerative Disc Disease in the lumbosacral spine.

General Overview of the Study Design

This is a multicenter, prospective, randomized, controlled clinical trial evaluating the safety and effectiveness of PRODISC® total disc replacement with spinal fusion surgery for the treatment of discogenic pain at one or two adjacent vertebral levels between L3 and S1. Up to fifteen centers will participate in this study.

The patients-assignment (randomization) will be performed using a 2 to 1 ratio of PRODISC® recipients to control spinal fusion recipients. There will be separate study arms for one and two level patients.

Patients will be assigned a treatment, either PRODISC® or spinal fusion surgery, according to a blocked randomization schedule. The block randomization will be stratified by the center and the number of vertebral levels involved, either 1 or 2.

Study Sponsor

Spine Solutions, Inc.

Status

Recruiting

Inclusion Criteria

Patients must have the following conditions and meet the following criteria to be enrolled in this study.

  • Degenerative Disc Disease (DDD) in one or two adjacent vertebral levels between L3 and S1. Diagnosis of DDD requires:

    a. Back and/or leg (radicular) pain; and
    b. Radiographic confirmation of any 1 of the following by CT, MRI, discography, plain film, myelography and/or flexion /extension films:

    i. Instability (³ 3mm translation or ³ 5° angulation);
    ii. Decreased disc height > 2mm;
    iii. Scarring/thickening of annulus fibrosis;
    iv. Herniated nucleus pulposus; or
    v. Vacuum phenomenon.

  • Age between 18 and 60 years.
     
  • Failed at least 6 months of conservative treatment.
     
  • Oswestry Low Back Pain Disability Questionnaire score of at least 20/50 (40%) (Interpreted as moderate/severe disability).
     
  • Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out of forms.

    Exclusion Criteria

    Patients who have any of the following conditions or meet any of the following criteria are excluded from participating in this study:

    1. No more than 2 vertebral levels may have DDD and all diseased levels, either one or two, must be treated.
       
    2. Known allergy to titanium, polyethylene, cobalt, chromium or molybdenum.
       
    3. Prior fusion surgery at any vertebral level.
       
    4. Clinically compromised vertebral bodies at the affected level(s) due to current or past trauma.
       
    5. Radiographic confirmation of facet joint disease or degeneration.
       
    6. Lytic spondylolisthesis or spinal stenosis.
       
    7. Degenerative spondylolisthesis of grade > 1.
       
    8. Back or leg pain of unknown etiology.
       
    9. Osteoporosis: A screening questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients who require a DEXA bone mineral density measurement. If DEXA is required, exclusion will be defined as a DEXA bone density measured T score £ -2.5 (The World Health Organization definition of osteoporosis.)
       
    10. Paget’s disease, osteomalacia or any other metabolic bone disease (excluding osteoporosis which is addressed above).
       
    11. Morbid obesity defined as a body mass index > 40 or a weight more than 100 lbs. over ideal body weight.
       
    12. Pregnant or interested in becoming pregnant in the next 3 years.
       
    13. Active infection - systemic or local.
       
    14. Taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids).
       
    15. Rheumatoid arthritis or other autoimmune disease.
       
    16. Systemic disease including AIDS, HIV, Hepatitis.
       
    17. Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there has been no clinical signs or symptoms of the malignancy for at least 5 years.
Updated on: 11/09/12
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