PCSS Surgery for Degenerative Disc Disease
(FUSE Trial)

Recruiting in Palo Alto (17 mi)

+16 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Providence Medical Technology, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This study will evaluate the safety and effectiveness of a device called "Posterior Cervical Stabilization System or PCSS" when used along with posterior cervical fusion (PCF) in combination with anterior cervical discectomy and fusion (ACDF) in the treatment of multi-level cervical degenerative disease.

Eligibility Criteria

Adults aged 18-80 with multi-level cervical degenerative disc disease unresponsive to non-surgical treatments, indicated for ACDF between C3-C7. Must be able to follow the study protocol and attend follow-ups. Excludes those with severe obesity, infections, certain previous spine conditions or surgeries, substance abuse issues, mental illness affecting consent or compliance, pregnancy plans within three years, recent investigational drug/device use.

Inclusion Criteria

I need surgery for disc disease in my neck between C3 and C7.

My doctor has approved me for surgery.

Written informed consent provided by subject

+4 more

Exclusion Criteria

I need daily high-dose steroids.

I have been diagnosed with a bone condition that is not osteoporosis.

I have severe neck pain due to disc or bone problems in my neck.

+24 more

Participant Groups

The trial is testing a device called PCSS alongside posterior cervical fusion and anterior cervical discectomy and fusion in treating multi-level degenerative disc disease of the neck. The goal is to assess safety and effectiveness of this combined surgical approach.

2Treatment groups

Experimental Treatment

Active Control

Group I: Circumferential Cervical Fusion (CCF)Experimental Treatment1 Intervention

Circumferential Cervical Fusion (CCF) is a combination of ACDF and Posterior Cervical Fusion (PCF) procedures. The PCF is completed with Posterior Cervical Stabilization System (PCSS).

Group II: Anterior Cervical Discectomy and Fusion (ACDF)Active Control1 Intervention

ACDF is a a standard of care procedure that is performed using standard instruments and completed with an allograft interbody implant and anterior plate. The plate is intended to stabilize the treated levels until fusion occurs.