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XL TDR® eXtreme Lateral Total Disc Replacement for the Treatment of Lumbar Degenerative Disc Disease (DDD)

NCT00927238 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2015-07-30

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and effectiveness of XL TDR in patients with single-level degenerative disc disease compared to other devices approved by the FDA for the same or similar indications.

Conditions

  • Degenerative Disc Disease

Interventions

DEVICE

XL TDR

This will be a lateral approach discectomy and reconstruction with the insertion of the XL TDR device.

OTHER

Lumbar fusion surgery

Lumbar fusion surgery

Sponsors & Collaborators

  • NuVasive

    lead INDUSTRY

Principal Investigators

  • William D Smith, MD · Western Regional Center for Brain and Spine Surgery

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2014-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

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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 NCT00927238 on ClinicalTrials.gov