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Clinical Outcomes of Lumbar Degenerative Disc Disease in Active-Duty U.S. Service Personnel

Primary Purpose

Degenerative Disc Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ProDisc™-L Total Disc Replacement (TDR)
Sponsored by
Synthes USA HQ, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Disc Disease focused on measuring DDD

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Degenerative Disc Disease (DDD) in one vertebral level between L3 and S1, where a diagnosis of DDD requires:

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

    i. Decreased disc height > 2 mm; ii. Scarring/thickening of annulus fibrosis; iii. Herniated nucleus pulposus; or iv. Vacuum phenomenon.

  2. Skeletally mature adult between the ages of 18 and 50 years at time of surgery.
  3. Failed at least 6 months of conservative therapy.
  4. Oswestry Low Back Pain Disability Questionnaire score ≥ 20/50 (40%) (Interpreted as moderate/severe disability).
  5. Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures.
  6. Plans to remain on active duty for a minimum of two (2) years.
  7. Personally signed and dated the informed consent document prior to any study-related procures indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

  1. More than one vertebral level to be treated.
  2. The involved vertebral endplates dimensionally smaller than 34.5 mm in the medial-lateral direction and/or 27 mm in the anterior-posterior direction.
  3. Known allergy to polyethylene, cobalt chromium, or molybdenum
  4. Prior fusion surgery at any lumbar vertebral level.
  5. Clinically compromised vertebral body at the affected level due to current or past trauma.
  6. Radiographic confirmation of facet joint disease or degeneration.
  7. Lytic spondylolisthesis or spinal stenosis.
  8. Degenerative spondylolisthesis > Grade 1.
  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.
  10. Known history of Paget's disease, osteomalacia, or any other metabolic bone disease.
  11. Morbid obesity defined as a body mass index > 40 kg/m2 or weight more than 100 pounds over ideal body weight.

Sites / Locations

  • Naval Medical Center - San Diego

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ProDisc L

Arm Description

Outcomes

Primary Outcome Measures

The Primary Endpoint of This Study is the Assessment of the Mean Oswestry Low Back Pain Disability Questionnaire (ODI) Improvement at the Twelve (12) Month and Twenty-four (24) Month Follow-up Visits Relative to Baseline.

Secondary Outcome Measures

Time to Return to Active Duty
No Re-operations, Revisions, Removals or Supplemental Fixation
No Implant Related Complications

Full Information

First Posted
December 8, 2009
Last Updated
February 2, 2016
Sponsor
Synthes USA HQ, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01028300
Brief Title
Clinical Outcomes of Lumbar Degenerative Disc Disease in Active-Duty U.S. Service Personnel
Official Title
Clinical Outcomes of Lumbar Degenerative Disc Disease Treated Operatively in Active-Duty U.S. Service Personnel With Lumbar Total Disc Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to enrollment failure
Study Start Date
April 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Degenerative disc disease (DDD) refers to a syndrome in which a degenerating disc causes chronic back pain, significantly impacting an individual's ability to function. The condition is most commonly diagnosed in the lumbosacral spinal segments L3-S1. The condition often starts with an injury to the disc space. The injury weakens the disc and creates excessive motion at the corresponding vertebral level. Over time, the segmental instability and associated neurological compromise combined with ongoing inflammatory processes that occur in and around the disc produce low back pain. The reparative processes in the disc are poor, thus the painful symptoms can become chronic. Premature degeneration at adjacent levels of the spine remains one of the more vexing problems facing spinal surgeons when advising relatively young people to consider lumbar fusion surgery. Stopping the motion changes the mechanics of the back (which is designed for motion and flexibility) and results in the transfer of the loads and stresses to the adjacent vertebral segments. It is therefore intuitive to pursue total disc replacement, which allows for the treatment of pain due to DDD while re-establishing motion and stability, load distribution, and restoring the disc height, as an alternative to spinal fusion surgery. The study hypothesis is that military personnel receiving Total Disc Replacement will return to the same level of active duty performance as at the time of their most recent successful physical readiness test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease
Keywords
DDD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ProDisc L
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
ProDisc™-L Total Disc Replacement (TDR)
Intervention Description
The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
Primary Outcome Measure Information:
Title
The Primary Endpoint of This Study is the Assessment of the Mean Oswestry Low Back Pain Disability Questionnaire (ODI) Improvement at the Twelve (12) Month and Twenty-four (24) Month Follow-up Visits Relative to Baseline.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Time to Return to Active Duty
Time Frame
24 months
Title
No Re-operations, Revisions, Removals or Supplemental Fixation
Time Frame
24 months
Title
No Implant Related Complications
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Degenerative Disc Disease (DDD) in one vertebral level between L3 and S1, where a diagnosis of DDD requires: Back and/or leg (radicular) pain; and Radiographic confirmation of any one of the following by CT, MRI, discography, plain film, myelography, and/or flexion/extension films: i. Decreased disc height > 2 mm; ii. Scarring/thickening of annulus fibrosis; iii. Herniated nucleus pulposus; or iv. Vacuum phenomenon. Skeletally mature adult between the ages of 18 and 50 years at time of surgery. Failed at least 6 months of conservative therapy. Oswestry Low Back Pain Disability Questionnaire score ≥ 20/50 (40%) (Interpreted as moderate/severe disability). Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures. Plans to remain on active duty for a minimum of two (2) years. Personally signed and dated the informed consent document prior to any study-related procures indicating that the subject has been informed of all pertinent aspects of the study. Exclusion Criteria: More than one vertebral level to be treated. The involved vertebral endplates dimensionally smaller than 34.5 mm in the medial-lateral direction and/or 27 mm in the anterior-posterior direction. Known allergy to polyethylene, cobalt chromium, or molybdenum Prior fusion surgery at any lumbar vertebral level. Clinically compromised vertebral body at the affected level due to current or past trauma. Radiographic confirmation of facet joint disease or degeneration. Lytic spondylolisthesis or spinal stenosis. Degenerative spondylolisthesis > Grade 1. 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. Known history of Paget's disease, osteomalacia, or any other metabolic bone disease. Morbid obesity defined as a body mass index > 40 kg/m2 or weight more than 100 pounds over ideal body weight.
Facility Information:
Facility Name
Naval Medical Center - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States

12. IPD Sharing Statement

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Clinical Outcomes of Lumbar Degenerative Disc Disease in Active-Duty U.S. Service Personnel

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