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RECRUITING
NCT06485206
NA

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.

Sponsor: Highridge Medical

View on ClinicalTrials.gov

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.

Official title: A Clinical Investigation Evaluating 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.

Key Details

Gender

All

Age Range

22 Years - 69 Years

Study Type

INTERVENTIONAL

Enrollment

97

Start Date

2024-09-01

Completion Date

2029-05

Last Updated

2025-01-27

Healthy Volunteers

No

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

Locations (2)

University of California-Davis

Sacramento, California, United States

Michigan Orthopaedic Surgeons

Southfield, Michigan, United States