Safety and Effectiveness Study of Prodisc to Spinal Fusion Surgery (PDL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Synthes USA HQ, Inc.
ClinicalTrials.gov Identifier:
NCT00295009
First received: February 20, 2006
Last updated: July 31, 2014
Last verified: July 2014
  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: ProDisc
Procedure: Spinal Fusion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Synthes USA HQ, Inc.:

Primary Outcome Measures:
  • Overall Success [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

    Overall success was a composite endpoint.

    A ProDisc patient was considered an overall success if, and only if, ALL of the following criteria were met:

    1. ODI score improved by at least 15% from baseline;
    2. SF-36 score improved from baseline;
    3. Neurologic parameters maintained or improved from baseline;
    4. No re-operations to modify or remove the implant; and
    5. Independent radiographic review confirmed no migration/subsidence, radiolucency, loss of disc height, loss of range of motion, or boney fusion.

    A Fusion patient was a considered to be a success if, and only if, ALL of the following criteria were met:

    1. Same as above
    2. Same as above
    3. Same as above
    4. No re-operations to modify the fusion site or correct a complication with an implant; and
    5. Independent radiographic review confirmed strong evidence of fusion and no motion, visible gaps in fusion mass, loss of disc height, migration/subsidence, implant loosening, halos, or radiolucencies

  • Overall Success [ Time Frame: 60 Months ] [ Designated as safety issue: No ]

    Overall success was a composite endpoint. A ProDisc patient was considered an overall success if, and only if, ALL of the following criteria were met:

    1. ODI score improved by at least 15% from baseline;
    2. SF-36 score improved from baseline;
    3. Neurologic parameters maintained or improved from baseline;
    4. No re-operations required to modify or remove the implant; and
    5. Independent radiographic review confirmed no migration/subsidence, radiolucency, loss of disc height, loss of range of motion, or boney fusion.

    A Fusion patient was a considered to be a success if, and only if, ALL of the following criteria were met:

    Items numbered 1-3, above; 4. No re-operations required to modify the fusion site or correct a complication with an implant; and 5. Independent radiographic review confirmed strong evidence of fusion and no motion, visible gaps in fusion mass, loss of disc height, migration/subsidence, implant loosening, halos, or radiolucencies



Enrollment: 852
Study Start Date: September 2001
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1-Level Fusion
Spinal fusion at a single lumbar level.
Procedure: Spinal Fusion
A circumferential fusion will be utilized as the control group in this study. The technique will consist of an interbody fusion procedure using commercially available femoral ring allograft. A posterior lateral fusion with autogenous iliac crest bone graft, combined with pedicle screw instrumentation.
Experimental: 1-Level ProDisc
Total disc replacement with the ProDisc device at one spinal lumbar level.
Device: ProDisc
Total disc replacement with ProDisc
Active Comparator: 2-Level Fusion
Spinal fusion at two adjacent lumbar levels.
Procedure: Spinal Fusion
A circumferential fusion will be utilized as the control group in this study. The technique will consist of an interbody fusion procedure using commercially available femoral ring allograft. A posterior lateral fusion with autogenous iliac crest bone graft, combined with pedicle screw instrumentation.
Experimental: 2-Level ProDisc
Total disc replacement with the ProDisc device at two adjacent lumbar levels.
Device: ProDisc
Total disc replacement with ProDisc
Experimental: 1-level ProDisc (non-randomized)
Total disc replacement with the ProDisc device for non-randomized subjects at one spinal lumbar level.
Device: ProDisc
Total disc replacement with ProDisc
Active Comparator: 2-Level ProDisc (Continued Access)
Total disc replacement with the ProDisc device for non-randomized subjects at two spinal lumbar levels (only followed out to 24 months)
Device: ProDisc
Total disc replacement with ProDisc

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Synthes USA HQ, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Synthes USA HQ, Inc.
ClinicalTrials.gov Identifier: NCT00295009     History of Changes
Other Study ID Numbers: PDL-07272001
Study First Received: February 20, 2006
Results First Received: June 18, 2014
Last Updated: July 31, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 21, 2014