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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.
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Inclusion criteria
Degenerative Disc Disease (DDD) in one vertebral level between L3 and S1, where a diagnosis of DDD requires:
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
Primary purpose
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Interventional model
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4 participants in 1 patient group
There are currently no registered sites for this trial.
Start date
Apr 01, 2010 • 14 years ago
End date
Mar 01, 2011 • 13 years ago
Results posted
ViewFeb 02, 2016 • 8 years ago
Today
Dec 30, 2024
Lead Sponsor
Data sourced from clinicaltrials.gov
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