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Evaluation of Safety and Effectiveness of Primary Hybrid Construct of Mobi-C and ACDF in the Treatment of Two-level Symptomatic Degenerative Disc Disease in the Cervical Spine.

NCT06485206 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2025-01-27

No results posted yet for this study

Summary

The study is a prospective, multi-center cohort study of patients with two-level DDD implanted with CDA adjacent to ACDF (hybrid construct). The overall success of the hybrid procedure will be compared to 2-level ACDF historical controls from the Mobi-C IDE trial. 97 patients will receive the hybrid surgery and will be followed for a minimum of 2 years.

Conditions

  • Degenerative Disc Disease

Interventions

DEVICE

One level Mobi-C and one level fusion

Cervical Disc Arthroplasty: • Mobi-C Fusion devices: * One-level cervical plates o MaxAn Cervical plate system * Interbody spacers * TrellOss-C - 3D printed Ti interbody * Vista-S - PEEK interbody * Standalone Fixation * Ti-Coated ROI-C - PEEK cage w/ Ti coating * TrellOss-C SA - 3D printed Ti * Bone Graft * Local Autograft * PrimaGen Advanced Allograft

Sponsors & Collaborators

  • Highridge Medical

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2029-05-31
Completion
2029-05-31
FDA Device
Yes

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 NCT06485206 on ClinicalTrials.gov