Clinical Outcomes of Lumbar Degenerative Disc Disease in Active-Duty U.S. Service Personnel
| Status: | Terminated |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 4/21/2016 |
| Start Date: | April 2010 |
| End Date: | March 2011 |
Clinical Outcomes of Lumbar Degenerative Disc Disease Treated Operatively in Active-Duty U.S. Service Personnel With Lumbar Total Disc Replacement
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.
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.
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
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.
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