PCSS Surgery for Degenerative Disc Disease

(FUSE Trial)

Not currently recruiting at 16 trial locations

Overseen By Stacey Underwood

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Providence Medical Technology, Inc.

Must not be taking: Epidural steroids, High-dose steroids, Opioids

Disqualifiers: Obesity, Infection, Cancer, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Surgical procedure duration

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new device, the Posterior Cervical Stabilization System (PCSS), to determine its safety and effectiveness in treating multi-level cervical degenerative disease, a condition causing neck pain and stiffness. The study compares the standard Anterior Cervical Discectomy and Fusion (ACDF) surgery with a new approach that combines ACDF with an additional procedure using the PCSS. Individuals with neck issues, such as degenerative disc disease between vertebrae C3-C7, who have not found relief from other treatments, might be suitable candidates.

As an unphased trial, this study provides patients the chance to explore innovative treatment options that could potentially enhance their quality of life.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using epidural steroids, you must stop at least 14 days before surgery.

What prior data suggests that the Posterior Cervical Stabilization System (PCSS) is safe for treating multi-level cervical degenerative disease?

Research has shown that the Posterior Cervical Stabilization System (PCSS) is generally safe for patients. Studies indicate that using PCSS alongside other surgical methods can enhance healing and reduce the need for additional surgeries. As a result, patients often require fewer follow-up operations, indicating good safety. Additionally, reports suggest that PCSS is safer compared to some other treatments.

Although specific details on side effects are not always provided, the positive healing rates and reduced need for further surgeries suggest that patients tolerate the treatment well. For those considering joining a trial, this information may help reassure them about the safety of PCSS. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Posterior Cervical Stabilization System (PCSS) because it offers a new approach for treating Degenerative Disc Disease. Unlike the standard Anterior Cervical Discectomy and Fusion (ACDF), which relies solely on anterior stabilization, the PCSS is part of a Circumferential Cervical Fusion (CCF) that combines both anterior and posterior stabilization techniques. This dual approach could potentially provide enhanced stability and support for the spine, which might lead to better fusion outcomes. By incorporating the PCSS, this method aims to improve overall surgical results and patient recovery experiences compared to existing treatments.

What evidence suggests that the Posterior Cervical Stabilization System (PCSS) is effective for degenerative disc disease?

Research has shown that the Posterior Cervical Stabilization System (PCSS) in neck surgeries holds promise for treating certain spine issues. In this trial, participants may undergo Circumferential Cervical Fusion (CCF), which combines anterior cervical discectomy and fusion (ACDF) with PCSS. Studies have found that patients receiving both ACDF and PCSS experienced better healing and quicker recovery than those with ACDF alone. One study found that this combination led to more effective and lasting results. Another study noted that this method is safer and more effective than ACDF alone. These findings suggest that adding PCSS to traditional neck surgeries could improve long-term outcomes. ^{1 3 4 6 7}

Who Is on the Research Team?

Matt Jenkins

Principal Investigator

Providence Medical Technology, Inc.

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Circumferential Cervical Fusion (CCF) or Anterior Cervical Discectomy and Fusion (ACDF) procedures

Surgical procedure duration

1 visit (in-person for surgery)

Follow-up

Participants are monitored for fusion success and safety outcomes

12 months

Regular follow-up visits

Extended Follow-up

Participants are monitored for long-term safety and effectiveness

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Posterior Cervical Stabilization System (PCSS)

Trial Overview 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.

How Is the Trial Designed?

Group I: Circumferential Cervical Fusion (CCF) Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

Providence Medical Technology, Inc.

Lead Sponsor

Trials

3

Recruited

240+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12323763/

Three-Level Anterior Cervical Discectomy and Fusion With or ... This trial was designed to understand safety and effectiveness outcomes in subjects with three-level cervical degenerative disc disease treated with anterior ...

2. providencemt.com providencemt.com/pcss-quick-study/

Cervical Fusion with CORUS™ PCSS Superior Fusion Outcomes Faster.12 months after surgery, patients treated with ACDF & CORUS PCSS demonstrated a clinically superior fusion rate compared to ...

3. prnewswire.com prnewswire.com/news-releases/landmark-clinical-study-published-in-spine-demonstrates-superiority-of-tissue-sparing-circumferential-cervical-fusion-over-acdf-alone-in-multilevel-cervical-fusion-surgery-302529792.html

Landmark Clinical Study Published in Spine Demonstrates ... "The science is clear: tissue-sparing CCF with CORUS PCSS is safer, more effective, and more durable than ACDF alone in multilevel cervical ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11355735/

Clinical Implementation of Tissue-Sparing Posterior Cervical ... Tissue-sparing posterior cervical fusion is an alternative method for treating patients with symptomatic cervical degenerative disc disease.

5. journals.lww.com journals.lww.com/neurosurgery/abstract/2025/04001/2020_impact_of_supplemental_posterior.629.aspx

2020 Impact of Supplemental Posterior Stabilization on... Achieving complete arthrodesis with anterior cervical discectomy and fusion (ACDF) helps ensure sustained relief of symptoms with outcomes at 2 years being ...

6. providencemt.com providencemt.com/corus-pcss/

CORUS PCSS Posterior Cervical Stabilization System (PCSS) · Superior Fusion Outcomes Faster* · Reduces Reoperation Rates · Superior Safety Outcomes.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04056520

Clinical and Radiological Outcomes of Posterior Cervical ... This is a prospective single arm study of clinical and radiological outcomes as well as surgical data from posterior cervical fusion for treating degenerative ...