Clinical Outcomes of Lumbar Degenerative Disc Disease in Active-Duty U.S. Service Personnel
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Outcomes of Lumbar Degenerative Disc Disease Treated Operatively in Active-Duty U.S. Service Personnel With Lumbar Total Disc Replacement|
- 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 ] [ Designated as safety issue: No ]
- Time to return to active duty [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- No re-operations, revisions, removals or supplemental fixation [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- No implant related complications [ Time Frame: 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2010|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Device: ProDisc™-L Total Disc Replacement (TDR)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01028300
|United States, California|
|Naval Medical Center - San Diego|
|San Diego, California, United States, 92134|