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Physical Capability Outcomes After Single-Level PD-L vs Single-Level ALIF: a Multi-Center Clinical Trial

NCT01055574 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2011-09-09

No results posted yet for this study

Summary

The purpose of this study is to compare the physical capability outcomes of patients who undergo single-level ProDisc-L disc replacement with those of patients who undergo stand-alone, single-level anterior lumbar interbody fusion (ALIF). This study will be the first multi-center clinical study to use clearly measurable outcomes from physical tests to compare the results of lumbar disc arthroplasty with disc fusion.

Conditions

  • Physical Capability Outcomes

Sponsors & Collaborators

  • Synthes USA HQ, Inc.

    collaborator INDUSTRY

  • Gundersen Lutheran Medical Foundation

    lead OTHER

Principal Investigators

  • Humbert (Drew) G Sullivan, MD · Gundersen Lutheran Health System, LaCrosse, WI

  • Jack E Zigler, MD · Texas Back Institute, Plano, TX

  • John G Devine, MD · Eisenhower Army Medical Center, Augusta, GA

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-12-31
Completion
2012-01-31

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 NCT01055574 on ClinicalTrials.gov