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Safety and Effectiveness Study of Prodisc to Spinal Fusion Surgery
This study is ongoing, but not recruiting participants.
Sponsored by: Synthes Spine
Information provided by: Synthes Spine
ClinicalTrials.gov Identifier: NCT00295009
  Purpose

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 DDD in the lumbosacral spine. There will be separate study arms for one and two level cases.


Condition Intervention
Spinal Diseases
Device: Total disc replacement

MedlinePlus related topics: Spinal Diseases
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multi-Center, Prospective, Randomized, Controlled Clinical Trial Comparing the Safety and Effectiveness of ProDisc to Spinal Fusion Surgery in the Treatment of Discogenic Pain Associated With DDD in the Lumbosacral Spine

Further study details as provided by Synthes Spine:

Estimated Enrollment: 510
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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: Instability (greater than or equal to 3mm translation or 5° angulation); Decreased disc height >2mm; Scarring/thickening of annulus fibrosis; Herniated nucleus pulposus; or 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 forms.
  • Signed informed consent.

Exclusion Criteria:

  • No more than 2 vertebral levels may have DDD and all diseased levels, either one or two, must be treated.
  • Patients with involved vertebral endplates dimensionally smaller than 34.5mm in the medial-lateral and/or 27mm in the anterior-posterior directions.
  • Known allergy to titanium, polyethylene, cobalt, chromium, or molybdenum.
  • Prior fusion surgery at any vertebral level.
  • Clinically compromised vertebral bodies at the affected level(s) due to current or past trauma.
  • Radiographic confirmation of facet joint disease or degeneration.
  • Lytic spondylolisthesis or spinal stenosis.
  • Degenerative spondylolisthesis of grade >1.
  • Back or leg pain of unknown etiology.
  • Osteopenia or Osteoporosis: A screening questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients to determine if a DEXA scan is required. If DEXA is required, exclusion will be defined as a DEXA bone density measured T score less than
  • 1.0. The World Health Organization defines osteoporosis as a DEXA T score less than or equal to -2.5.
  • Paget's disease, osteomalacia or any other metabolic bone disease (excluding osteoporosis which is addressed above).
  • Morbid obesity defined as a body mass index >40 or a weight more than 100 lbs. over ideal body weight.
  • Pregnant or interested in becoming pregnant in the next 3 years.
  • Active infection - systemic or local.
  • Taking medication or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids).
  • Rheumatoid arthritis or other autoimmune disease.
  • Systemic disease including AIDS, HIV, Hepatitis.
  • 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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Study ID Numbers: PDL-07272001
Study First Received: February 20, 2006
Last Updated: February 21, 2006
ClinicalTrials.gov Identifier: NCT00295009  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Spinal Diseases
Musculoskeletal Diseases
Pain
Bone Diseases

ClinicalTrials.gov processed this record on January 16, 2009