NCT00942045

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

Osteocel® Plus in Anterior Cervical Discectomy and Fusion (ACDF): Evaluation of Radiographic and Patient Outcomes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 182 (actual)
• Sponsor: NuVasive · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Detailed description

A total of 175 subjects will be selected for enrollment in this study from multiple centers. The subjects will have degenerative conditions in the cervical spine and will be undergoing ACDF surgery as treatment at one or two levels. The following eligibility criteria are designed to select subjects for whom protocol treatment is considered appropriate. All relevant medical and non-medical conditions should be taken into consideration when deciding whether this protocol is suitable for a particular subject.

Conditions

• Degenerative Disc Disease in Cervical Spine

Interventions

Type	Name	Description
BIOLOGICAL	Biologic - Osteocel Plus	Osteocel Plus

Timeline

• Start date: 2009-02-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2009-07-20
• Last updated: 2025-12-24

Locations

17 sites across 1 country: United States