MedTrace Logo

Trinity Evolution in Anterior Cervical Disectomy and Fusion (ACDF)

NCT00951938 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2014-04-08

No results posted yet for this 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

  • Degenerative Disc Disease

Sponsors & Collaborators

  • Orthofix Inc.

    lead INDUSTRY

Principal Investigators

  • Raymond J Linovitz, MD · Orthofix Spinal Implants

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00951938 on ClinicalTrials.gov