NCT05812092

Treatment of One and/or Two Level Cervical Degenerative Disc Disease

A Prospective Clinical/Radiological Outcome Study of the CONDUIT™ Interbody Cervical System With Supplemental Fixation for the Treatment of One and/or Two Level Cervical Degenerative Disc Disease and/or Cervical Spinal Instability

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Research Source · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to collect clinical and radiographic outcomes using the CONDUIT™ Interbody Cervical System with supplemental fixation using a DePuy Synthes Cervical Plating System.

Detailed description

The primary aim of this study is to evaluate the performance of the CONDUITTM Interbody Cervical System in reducing pain and degree of disability as measured using the Neck Disability Index (NDI). Recruitment will occur from the patient population of the investigator. All patients will be evaluated for participation in the study by using the inclusion/exclusion listed below. Subjects need to meet all the inclusion and none of the exclusion. The responsibility is exclusively maintained by the investigator of any potential study participant as defined by the inclusion/ exclusion. Patients will consent to participating in the study, prior to any study procedures.

Conditions

• Cervical Radiculopathy

Interventions

Type	Name	Description
DEVICE	CONDUIT Interbody Cervical System with DePuy Synthes Cervical Plating System	CONDUIT Interbody Cervical System will be inserted between C2 through T1 and fixated using a DePuy Synthes Cervical Plating System at 1 or 2 levels.

Timeline

• Start date: 2021-05-01
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2023-04-13
• Last updated: 2025-08-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study