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Clinical Outcome Study of the Triad Allograft for Posterior Lumbar Fusion

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ClinicalTrials.gov Identifier: NCT00205101
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
NuVasive
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief 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.

Condition or disease
Pain Stenosis Spondylolisthesis

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Study Type : Observational
Actual Enrollment : 37 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Outcome Study of the Triad Allograft for Posterior Lumbar Fusion
Study Start Date : September 2004
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Group/Cohort
1
Triad allograft
2
other anterior lumbar interbody fusion (ALIF)
3
transforaminal lumbar interbody fusion (TLIF)
4
posterior lumbar interbody fusion (PLIF)




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
70 consecutive patients treated by lumbar fusion using the Triad allograft
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00205101


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

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00205101     History of Changes
Other Study ID Numbers: HSC# 2004-0235
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

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:
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Spondylolisthesis
Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases