Clinical Outcomes of Lumbar Degenerative Disc Disease in Active-Duty U.S. Service Personnel
|ClinicalTrials.gov Identifier: NCT01028300|
Recruitment Status : Terminated (Terminated due to enrollment failure)
First Posted : December 9, 2009
Results First Posted : February 2, 2016
Last Update Posted : March 2, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Degenerative Disc Disease||Device: ProDisc™-L Total Disc Replacement (TDR)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Outcomes of Lumbar Degenerative Disc Disease Treated Operatively in Active-Duty U.S. Service Personnel With Lumbar Total Disc Replacement|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
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.
- 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 ]
- Time to Return to Active Duty [ Time Frame: 24 months ]
- No Re-operations, Revisions, Removals or Supplemental Fixation [ Time Frame: 24 months ]
- No Implant Related Complications [ Time Frame: 24 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01028300
|United States, California|
|Naval Medical Center - San Diego|
|San Diego, California, United States, 92134|