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COMPLETED

Trinity Evolution in Anterior Cervical Disectomy and Fusion (ACDF)

NCT00951938 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 200 participants
Start Date 2009-08
Est. Completion 2012-08

Sponsor

Orthofix

6 total trials

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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. 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 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Orthofix, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Degenerative Disc Disease 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: NCT00951938 reports 13 study locations spanning 10 distinct geographic areas — top geographies include California, North Carolina, Virginia. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

Who is sponsoring clinical trial NCT00951938?

This trial is sponsored by Orthofix, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial