MedTrace Logo

Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty

NCT00931515 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-05-26

Study results available
· View outcomes & findings →

Summary

The NuBac device is indicated for reconstruction following nucleotomy in skeletally mature patients at least 18 years of age with symptomatic single level degenerative disc disease (DDD) at L4/L5 only.

DDD is defined as discogenic back pain with or without leg pain; with degeneration of the disc as confirmed by patient history, physical examination, radiographic studies showing: decreased disc height, contained herniated nucleus, vacuum phenomenon (dark disc) OR positive discography at the affected level.

These DDD patients should have no more than Grade 1 spondylolisthesis at the involved level and should have failed at least six months of conservative, non-operative care.

Demonstrate non-inferiority compared to ProDisc.

Conditions

  • Degenerative Disc Disease

Interventions

DEVICE

NuBac

NuBac device implanted at the L4/5 level.

DEVICE

Prodisc-L

Prodisc-L implanted at the L4/5 level.

Sponsors & Collaborators

  • Pioneer Surgical Technology, Inc.

    lead INDUSTRY

Principal Investigators

  • Matthew Songer, MD · Orthopedic Surgery Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2012-12-31
Completion
2012-12-31

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 NCT00931515 on ClinicalTrials.gov