Clinical Outcome Study of the Triad Allograft for Posterior Lumbar Fusion

This study has been completed.
Sponsor:
Collaborator:
NuVasive
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00205101
First received: September 13, 2005
Last updated: December 14, 2007
Last verified: December 2007

September 13, 2005
December 14, 2007
September 2004
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Complete list of historical versions of study NCT00205101 on ClinicalTrials.gov Archive Site
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Clinical Outcome Study of the Triad Allograft for Posterior Lumbar Fusion
Clinical Outcome Study of the Triad Allograft for Posterior Lumbar Fusion

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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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  • Pain
  • Stenosis
  • Spondylolisthesis
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  • 1
    Triad allograft
  • 2
    other anterior lumbar interbody fusion (ALIF)
  • 3
    transforaminal lumbar interbody fusion (TLIF)
  • 4
    posterior lumbar interbody fusion (PLIF)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
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Inclusion Criteria:

  1. Voluntary consent for an observational study
  2. One of the following diagnoses:

    • isthmic spondylolisthesis,
    • degenerative spondylolisthesis,
    • pseudoarthritis,
    • severe foraminal stenosis, and
    • prior failed discectomies
  3. Single, two, or three level fusions
  4. Patients require treatment by TLIF or PLIF posterior fusion as determined by surgeon. Pedicle screw instrumentation will be placed in all cases.

Exclusion Criteria:

  1. Infection at operative site
  2. Severe osteoporosis
  3. Inability to return for follow-up.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00205101
HSC# 2004-0235
Not Provided
Paul Anderson MD, University of Wisconsin
University of Wisconsin, Madison
NuVasive
Principal Investigator: Paul Anderson, MD University of Wisconsin, Madison
University of Wisconsin, Madison
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP