NCT06485206

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.

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 97 (estimated)
• Sponsor: Highridge Medical · Industry
• Sex: All
• Age: 22 Years – 69 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2024-09-01
• Primary completion: 2029-05-01
• Completion: 2029-05-01
• First posted: 2024-07-03
• Last updated: 2025-01-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study