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Clinical Outcome Study of the Triad Allograft for Posterior Lumbar Fusion
NCT00205101 · View on ClinicalTrials.gov ↗
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 Studied
Study Locations (1)
Wisconsin
- UW Health Spine Clinic — Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2004-09 |
| Est. Completion | 2009-04 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00205101
The ClinicalTrials.gov registry entry for NCT00205101 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 943 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Pain appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00205101 reports 1 study location spanning 1 distinct geographic area — top geographies include Wisconsin. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00205101 about?
NCT00205101 is a clinical study titled "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 lumba...
What is the current status of trial NCT00205101?
This trial is currently completed. The enrollment target is 37 participants. The study started on 2004-09. Estimated completion is 2009-04.
What conditions does trial NCT00205101 study?
This clinical trial studies the following conditions: Pain, Spondylolisthesis, Stenosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT00205101?
This trial is sponsored by University of Wisconsin, Madison, which has 943 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00205101 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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