CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 81 enrolled
Drug / intervention
Cellentra VCBMbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02182843
NCT02182843N/ACompleted
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Cellentra Viable Cell Bone Matrix (VCBM) Anterior Cervical Discectomy and Fusion Outcomes Study (VCBM/MaxAn)

Zimmer Biomet·interventional·Posted Jul 8, 2014·Updated Mar 15, 2019

In Brief

A clinical study evaluating Cellentra VCBM for Cervical Disc Degenerative Disorder. Completed, enrolled 81 participants across 6 sites.

Detailed Summary

The purpose of this study is to assess the clinical and radiographic outcomes in patients who undergo ACDF procedures using Cellentra Viable Cell Bone Matrix (VCBM), cortical allograft spacers, and the MaxAn® Anterior Cervical Plate System. Cellentra VCBM will be compared to published data for autograft in NDI (Neck Disability Index) improvement and radiographic success of fusion.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Disc Degenerative Disorder
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 8, 2014
Enrollment StartMar 1, 2014
Primary CompletionJan 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 12.0 years ago

Interventions

Cellentra VCBMbiological

Cellentra™ VCBM is an allogenic bone graft containing naturally occurring viable donor cells intended for homologous use in the repair, replacement, reconstruction or supplementation of the recipient's tissue in musculoskeletal defects.