MedTrace Logo

A Pilot Study of the InterCushion Disc Nucleus Prosthesis (DNP) in Patients Receiving Discectomy

NCT01652053 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2016-11-02

No results posted yet for this study

Summary

The primary endpoints of the investigation will include assessment of the maintenance of disc height demonstrated by radiographic evidence based on plain radiographs and MRI and relief of pain as measured by Visual Analog Scale (VAS) at six months post-surgery. It is anticipated that outcomes with the InterCushion Disc Nucleus Prosthesis (DNP) will be comparable to or better than the historical published results for discectomy alone.

Conditions

  • Disk, Herniated

Interventions

DEVICE

Disc Nucleus Replacement (InterCushion DNP)

The device is intended for spinal arthroplasty in skeletally mature patients with leg pain due to a herniated disc with or without back pain, who are having a discectomy at one level from L2 -S1. These patients should have no spondylolisthesis at the involved level.

Sponsors & Collaborators

  • Vertebral Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Phillip F de Muelanaere, MD · Brandon General Hospital

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2018-01-31
Completion
2018-06-30

Countries

  • Canada

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 NCT01652053 on ClinicalTrials.gov