search
Back to results

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

Primary Purpose

Spinal Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ProDisc
Spinal Fusion
Sponsored by
Synthes USA HQ, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Diseases

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Active Comparator

    Experimental

    Active Comparator

    Experimental

    Experimental

    Active Comparator

    Arm Label

    1-Level Fusion

    1-Level ProDisc

    2-Level Fusion

    2-Level ProDisc

    1-level ProDisc (non-randomized)

    2-Level ProDisc (Continued Access)

    Arm Description

    Spinal fusion at a single lumbar level.

    Total disc replacement with the ProDisc device at one spinal lumbar level.

    Spinal fusion at two adjacent lumbar levels.

    Total disc replacement with the ProDisc device at two adjacent lumbar levels.

    Total disc replacement with the ProDisc device for non-randomized subjects at one spinal lumbar level.

    Total disc replacement with the ProDisc device for non-randomized subjects at two spinal lumbar levels (only followed out to 24 months)

    Outcomes

    Primary Outcome Measures

    Overall Success
    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: ODI score improved by at least 15% from baseline; SF-36 score improved from baseline; Neurologic parameters maintained or improved from baseline; No re-operations to modify or remove the implant; and 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: Same as above Same as above Same as above No re-operations to modify the fusion site or correct a complication with an implant; and 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
    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: ODI score improved by at least 15% from baseline; SF-36 score improved from baseline; Neurologic parameters maintained or improved from baseline; No re-operations required to modify or remove the implant; and 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

    Secondary Outcome Measures

    Full Information

    First Posted
    February 20, 2006
    Last Updated
    July 31, 2014
    Sponsor
    Synthes USA HQ, Inc.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00295009
    Brief Title
    Safety and Effectiveness Study of Prodisc to Spinal Fusion Surgery
    Acronym
    PDL
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2001 (undefined)
    Primary Completion Date
    April 2011 (Actual)
    Study Completion Date
    April 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Synthes USA HQ, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    852 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1-Level Fusion
    Arm Type
    Active Comparator
    Arm Description
    Spinal fusion at a single lumbar level.
    Arm Title
    1-Level ProDisc
    Arm Type
    Experimental
    Arm Description
    Total disc replacement with the ProDisc device at one spinal lumbar level.
    Arm Title
    2-Level Fusion
    Arm Type
    Active Comparator
    Arm Description
    Spinal fusion at two adjacent lumbar levels.
    Arm Title
    2-Level ProDisc
    Arm Type
    Experimental
    Arm Description
    Total disc replacement with the ProDisc device at two adjacent lumbar levels.
    Arm Title
    1-level ProDisc (non-randomized)
    Arm Type
    Experimental
    Arm Description
    Total disc replacement with the ProDisc device for non-randomized subjects at one spinal lumbar level.
    Arm Title
    2-Level ProDisc (Continued Access)
    Arm Type
    Active Comparator
    Arm Description
    Total disc replacement with the ProDisc device for non-randomized subjects at two spinal lumbar levels (only followed out to 24 months)
    Intervention Type
    Device
    Intervention Name(s)
    ProDisc
    Intervention Description
    Total disc replacement with ProDisc
    Intervention Type
    Procedure
    Intervention Name(s)
    Spinal Fusion
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Overall Success
    Description
    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: ODI score improved by at least 15% from baseline; SF-36 score improved from baseline; Neurologic parameters maintained or improved from baseline; No re-operations to modify or remove the implant; and 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: Same as above Same as above Same as above No re-operations to modify the fusion site or correct a complication with an implant; and 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
    Time Frame
    24 Months
    Title
    Overall Success
    Description
    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: ODI score improved by at least 15% from baseline; SF-36 score improved from baseline; Neurologic parameters maintained or improved from baseline; No re-operations required to modify or remove the implant; and 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
    Time Frame
    60 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23082849
    Citation
    Zigler JE, Glenn J, Delamarter RB. Five-year adjacent-level degenerative changes in patients with single-level disease treated using lumbar total disc replacement with ProDisc-L versus circumferential fusion. J Neurosurg Spine. 2012 Dec;17(6):504-11. doi: 10.3171/2012.9.SPINE11717. Epub 2012 Oct 19.
    Results Reference
    derived

    Learn more about this trial

    Safety and Effectiveness Study of Prodisc to Spinal Fusion Surgery

    We'll reach out to this number within 24 hrs