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

NCT01028300 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2016-03-02

Study results available
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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.

Conditions

  • Degenerative Disc Disease

Interventions

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.

Sponsors & Collaborators

  • Synthes USA HQ, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01028300 on ClinicalTrials.gov