PCSS Surgery for Degenerative Disc Disease

(FUSE Trial)

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

236 Participants Needed

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.

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 data supports the effectiveness of the treatment Posterior Cervical Stabilization System (PCSS) for Degenerative Disc Disease?

Research on similar treatments, like posterior cervical fusion and decompression, shows that these procedures can improve neck alignment and reduce pain in patients with degenerative disc disorders. This suggests that the Posterior Cervical Stabilization System (PCSS) might also be effective for similar conditions. ^{1 2 3 4 5}

Is the Posterior Cervical Stabilization System (PCSS) surgery safe for humans?

The Posterior Cervical Stabilization System (PCSS), also known as the cervical pedicle screw (CPS) system, has been shown to be safe in humans, even with the freehand technique. However, surgeries involving the posterior cervical spine, like posterior cervical decompression and fusion, can have complications such as blood loss, infection, and nerve issues, with overall complication rates ranging from 15% to 25%. ^{3 6 7 8 9}

How is the Posterior Cervical Stabilization System (PCSS) treatment different from other treatments for degenerative disc disease?

The Posterior Cervical Stabilization System (PCSS) is unique because it focuses on stabilizing the spine from the back (posterior approach), which may offer benefits in preserving motion and reducing the risk of adjacent segment disease compared to traditional fusion surgeries. This approach can be less invasive and may be performed in an outpatient setting, potentially leading to quicker recovery times. ^{5 10 11 12 13}

Research Team

Matt Jenkins

Principal Investigator

Providence Medical Technology, Inc.

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

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Higher reoperation rate following cervical disc replacement in a retrospective, long-term comparative study of 715 patients. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Improved Sagittal Alignment Is Associated with Early Postoperative Neck Disability and Pain-Related Patient-Reported Outcomes Following Posterior Cervical Decompression and Fusion for Myelopathy. [2022]

3. Japan pubmed.ncbi.nlm.nih.gov

Radiographic Outcomes of Upper Cervical Fusion for Pediatric Patients Younger Than 10 Years. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

One-stage posterior decompression and reconstruction of the cervical spine by using pedicle screw fixation systems. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Outcomes of posterior cervical fusion and decompression: a systematic review and meta-analysis. [2020]

6. China pubmed.ncbi.nlm.nih.gov

Pedicle screw fixation for cervical spine instability: clinical efficacy and safety analysis. [2009]

7. China pubmed.ncbi.nlm.nih.gov

Complications following posterior cervical decompression and fusion: a review of incidence, risk factors, and prevention strategies. [2020]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Preoperative Narcotic Use, Impaired Ambulation Status, and Increased Intraoperative Blood Loss Are Independent Risk Factors for Complications Following Posterior Cervical Laminectomy and Fusion Surgery. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Analysis of the Fusion and Graft Resorption Rates, as Measured by Computed Tomography, 1 Year After Posterior Cervical Fusion Using a Cervical Pedicle Screw. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Cervical Spine Surgery: Arthroplasty Versus Fusion Versus Posterior Foraminotomy. [2021]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Is It Necessary to Cross the Cervicothoracic Junction in Posterior Cervical Decompression and Fusion for Multilevel Degenerative Cervical Spine Disease? A Systematic Review and Meta-Analysis. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Smoking Is an Independent Risk Factor for 90-Day Readmission and Reoperation Following Posterior Cervical Decompression and Fusion. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Comparison of the Biomechanical Changes After Percutaneous Full-Endoscopic Anterior Cervical Discectomy versus Posterior Cervical Foraminotomy at C5-C6: A Finite Element-Based Study. [2020]