MedTrace Logo

Clinical Outcome Study of the Triad Allograft for Posterior Lumbar Fusion

NCT00205101 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 37

Last updated 2019-03-13

No results posted yet for this study

Summary

The purpose of the study is to prospectively measure pain, function, and patient satisfaction in 70 consecutive patients treated by lumbar fusion using the Triad allograft. Results of the Triad allograft will be compared to those of other anterior lumbar interbody fusion (ALIF), transforaminal lumbar interbody fusion (TLIF), and posterior lumbar interbody fusion (PLIF) surgeries. Patient participation is based on the physician determination that the patient requires one of these surgeries. Participants will be evaluated pre-operatively and post-operatively at 3, 6, 12,and 24 month intervals. Clinic procedures will be related to standard of care except for the completion of several study questionnaires:

1. Back Pain Questionnaire;
2. Oswestry Disability Index Questionnaire;
3. Short Form-36 (SF-36) Survey;
4. Visual Analog Pain Scale (VAS); and
5. The Modems Patient Satisfaction Survey.

Outcome Measurements:

1. The patient's pain is scored by a VAS normalized to 100;
2. Patient function is based on Oswestry scores;
3. General health is assessed by SF-36 completion; and
4. Overall patient satisfaction will be determined by the completion of the Modems.

Conditions

  • Pain
  • Stenosis
  • Spondylolisthesis

Sponsors & Collaborators

  • NuVasive

    collaborator INDUSTRY

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Paul Anderson, MD · University of Wisconsin, Madison

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00205101 on ClinicalTrials.gov