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
  Purpose

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.

Condition
Pain
Stenosis
Spondylolisthesis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Outcome Study of the Triad Allograft for Posterior Lumbar Fusion

Further study details as provided by University of Wisconsin, Madison:

Estimated Enrollment: 70
Study Start Date: September 2004
Groups/Cohorts
1
Triad allograft
2
other anterior lumbar interbody fusion (ALIF)
3
transforaminal lumbar interbody fusion (TLIF)
4
posterior lumbar interbody fusion (PLIF)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205101

Locations
United States, Wisconsin
UW Health Spine Clinic
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
NuVasive
Investigators
Principal Investigator: Paul Anderson, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: Paul Anderson MD, University of Wisconsin
ClinicalTrials.gov Identifier: NCT00205101     History of Changes
Other Study ID Numbers: HSC# 2004-0235
Study First Received: September 13, 2005
Last Updated: December 14, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Transforaminal lumbar interbody fusion
Posterior lumbar interbody fusion
Isthmic spondylolisthesis, degenerative spondylolisthesis
Pseudoarthritis
Severe Foraminal Stenosis

Additional relevant MeSH terms:
Spondylolisthesis
Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 18, 2014