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Osteocel® Plus in Anterior Cervical Discectomy and Fusion (ACDF)

NCT00942045 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 182

Last updated 2025-12-24

No results posted yet for this study

Summary

This is a prospective, non-randomized multi-center study to compare the use of Osteocel Plus in subjects who receive ACDF surgery at one or two levels. These subjects will present with degenerative conditions in the cervical spine that are amenable to surgical treatment and will be screened prior to study enrollment. Subjects will receive Osteocel Plus, without any other biologic product, during their ACDF operation. The ACDF procedure will be conducted with a radiolucent graft containment device such that progression of fusion can be adequately assessed via radiograph. Subjects will be followed for 24-months following surgery to determine the number of study subjects that are solidly fused at or before 24 months postoperatively, and to determine the mean time to fusion. This data will be compared to published and/or retrospective data for autograft, synthetic ceramics and Bone Morphogenetic Protein (BMP).

Conditions

  • Degenerative Disc Disease in Cervical Spine

Interventions

BIOLOGICAL

Biologic - Osteocel Plus

Osteocel Plus

Sponsors & Collaborators

  • NuVasive

    lead INDUSTRY

Principal Investigators

  • Kelli Howell, MS · NuVasive

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States

Study Locations

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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 NCT00942045 on ClinicalTrials.gov