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

NCT01028300 | Terminated Results DMC

• 1 other identifier: Military ProDisc-L Study
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

DDD

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (3)

• Time to Return to Active Duty

  24 months

• No Re-operations, Revisions, Removals or Supplemental Fixation

  24 months

• No Implant Related Complications

  24 months

Study Arms (1)

ProDisc L

OTHER

Device: ProDisc™-L Total Disc Replacement (TDR)

Interventions

ProDisc™-L Total Disc Replacement (TDR) DEVICE

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.

ProDisc L

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Degenerative Disc Disease (DDD) in one vertebral level between L3 and S1, where a diagnosis of DDD requires:
• Back and/or leg (radicular) pain; and
• 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.
• 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.

You may not qualify if:

• More than one vertebral level to be treated.
• The involved vertebral endplates dimensionally smaller than 34.5 mm in the medial-lateral direction and/or 27 mm in the anterior-posterior direction.
• Known allergy to polyethylene, cobalt chromium, or molybdenum
• Prior fusion surgery at any lumbar vertebral level.
• Clinically compromised vertebral body at the affected level due to current or past trauma.
• Radiographic confirmation of facet joint disease or degeneration.
• Lytic spondylolisthesis or spinal stenosis.
• Degenerative spondylolisthesis \> Grade 1.
• Known history of Paget's disease, osteomalacia, or any other metabolic bone disease.
• Morbid obesity defined as a body mass index \> 40 kg/m2 or weight more than 100 pounds over ideal body weight.

Sponsors & Collaborators

• Synthes USA HQ, Inc.: lead

Study Sites (1)

Naval Medical Center - San Diego

San Diego, California, 92134, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Limitations and Caveats

Study was terminated early due to slow enrollment. Only Two subjects were seen for follow-up visits, and only at 3 months post surgery.

Results Point of Contact

• Title: Mark Lotito
• Organization: DePuy Synthes Spine

mlotito@its.jnj.com

508-880-8045

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2009
• First Posted: December 9, 2009
• Study Start: April 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: March 2, 2016
• Results First Posted: February 2, 2016

Record last verified: 2016-02

Locations

US (1)