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.

Part of paid clinical trials in Sacramento, California.

Sponsor
Highridge Medical
Study ID
NCT06485206
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

  • One level Mobi-C and one level fusion — DEVICE
    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

Study Details

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.

Key Dates

Start date
Sep 1, 2024
Status verified
Sep 2024
Primary completion
May 31, 2029
Completion
May 31, 2029

Study Design

Enrollment
97 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Primary Hybrid Construct
    Primary hybrid surgery is when patients undergo CDA and ACDF at the same time.

Primary Outcome Measure

Composite Success [ Time Frame: 24 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California-DavisSacramentoCalifornia95816
Janice Wang-Polagruto, PhD
[email protected]
916-551-3244
Kee Kim, MD (PRINCIPAL_INVESTIGATOR)
Michigan Orthopaedic SurgeonsSouthfieldMichigan48033
Cameron Goldie
[email protected]
248-416-1243
Jad Khalil, MD (PRINCIPAL_INVESTIGATOR)

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