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NCT00951938 · ClinicalTrials.gov registry record
Trinity Evolution in Anterior Cervical Disectomy and Fusion (ACDF)
A clinical trial of Degenerative Disc Disease, sponsored by Orthofix.
- Completed
- Registry status
- 200
- Enrollment target
- 13
- Study locations
NCT00951938 is a study of Degenerative Disc Disease that has completed, run by Orthofix. The registered enrollment target is 200 participants, above the 164-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (22% higher). The trial reports 13 study locations across 10 states.
The verdict
NCT00951938, a study of Degenerative Disc Disease, has completed, sponsored by Orthofix.
- COMPLETED
- Registry status
- 200 participants
- Enrollment target
- 13
- Study locations
Study Summary
The purpose of this study is to utilize Trinity Evolution in conjunction with an interbody spacer and supplemental anterior fixation of the surgeon's choice and to follow the patients to measure the clinical outcomes and rate of fusion. The hypothesis of the study is that Trinity Evolution combined with an interbody spacer and supplemental anterior fixation will result in fusion rates and clinical outcomes similar to those with other routinely used autograft and allograft materials including: fusion, improvement in pain and function, maintenance of upper extremity neurological function, and absence of serious adverse events related to the use of the Trinity Evolution product.
Conditions Studied
Study Locations (13)
California
- CORE Orthopaedic Medical Center - Encinitas
- Shasta Orthopaedics Spine Center - Redding
North Carolina
- Carolina NeuroSurgery & Spine - Charlotte
- Triangle Neurosurgery - Raleigh
Virginia
- The Virginia Spine Institute - Reston
- Tuckahoe Orthopaedic Associates - Richmond
Colorado
- Denver-Vail Orthopedics, P.C. - Parker
Connecticut
- Central Connecticut Neurosurgery and Spine - New Britain
Kansas
- Kansas University Medical Center - Kansas City
Michigan
- University of Michigan, A. Alfred Taubman Health Care Center - Ann Arbor
Nevada
- Western Regional Center for Spine and Brain Surgery - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2009-08 |
| Est. Completion | 2012-08 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00951938
The ClinicalTrials.gov registry entry for NCT00951938 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 164-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (22% higher). The listed sponsor is Orthofix, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Degenerative Disc Disease appearing as the primary indexed condition, and to 0 interventions.
NCT00951938 reports 13 study locations spanning 10 distinct geographic areas - top geographies include California, North Carolina, Virginia.
Frequently Asked Questions
What is clinical trial NCT00951938 about?
NCT00951938 is a clinical study titled "Trinity Evolution in Anterior Cervical Disectomy and Fusion (ACDF)". The purpose of this study is to utilize Trinity Evolution in conjunction with an interbody spacer and supplemental anterior fixation of the surgeon's choice and to follow the patients to measure the clinical outcomes and rate of fusion. The hypothesis of the study is that Trinity Evolution combined ...
What is the current status of trial NCT00951938?
This trial is currently completed. The enrollment target is 200 participants. The study started on 2009-08. Estimated completion is 2012-08.
What conditions does trial NCT00951938 study?
This clinical trial studies the following conditions: Degenerative Disc Disease.
Who is sponsoring clinical trial NCT00951938?
This trial is sponsored by Orthofix, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00951938 being conducted?
This trial has 13 study locations across California, Colorado, Connecticut, Kansas, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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