Call 833-321-3873 for more information

Considering fusion surgery for your neck?

We invite you to join our official Clinical Study.

Space is limited — Secure your spot today.

You may qualify for this study if you:

Have pain or numbness in your neck, shoulders, arms, or hands

Have not had a previous fusion surgery on your neck

Have Medicare or other medical insurance

Your Benefits:

Investigational Treatment Technology *

Attentive Care from Spine Specialists

Contribute to Medical Research

Participants Receive Reimbursement †

About the FUSE Study

This clinical study is evaluating whether the Posterior Cervical Stabilization System (“PCSS”) improves fusion rates for cervical fusion patients when used as part of Circumferential Cervical Fusion.

Study Hypothesis

Patients who receive circumferential fusion with PCSS will have a higher rate of fusion and fewer surgical failures.

Innovative, Investigational Cervical Stabilization System *

Posterior Cervical Stabilization System (“PCSS”) is a small metal implant placed in spinal joints on the neck’s back. When used as part of posterior cervical fusion (PCF), PCSS is designed to be used with an ACDF to stabilize the spine, which may improve fusion rates and results.

The technology and procedure are unique because a surgeon uses a small tube about the size of a large straw to place PCSS in the spine.

Pictured: The location of incisions and the Guide Tube used to access the spinal joints during surgery. Click image to enlarge.

Pictured: PCSS in a facet joint (spinal joint space) as part of a posterior cervical fusion. Click image to enlarge.

Are You Eligible?

Call 833-321-3873 or answer 4 simple questions

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Attentive Care from Spine Specialists & Health Professionals

Receive regular, careful medical attention from a research team that includes spine surgeons and other health professionals at respected medical institutions.

Dr. Sandeep Gidvani, MD

Dr. Sandeep N. Gidvani, MD is the study investigator and care provider serving the greater San Jose CA area.

Dr. Gidvani is a board-certified & fellowship-trained orthopedic spine & neck surgeon with extensive experience in the latest spinal surgery treatments and techniques.

OrthoNorCal
340 Dardanelli Ln #10
Los Gatos, CA 95032

Dr. Sandeep N. Gidvani, MD

Contribute to Research of Spinal Therapies & Treatment

By participating in this study, you will be helping to advance the understanding of spinal surgery, which may improve care for future patients.

Receive Reimbursement for Time & Travel

The study reimburses study participants for their time and travel costs. Your doctor will provide reimbursement details.

Get More Information

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Has this kind of surgery ever been done before this clinical study?

Yes. Both anterior and posterior cervical fusions are commonly performed and considered safe and effective.

Surgeons in the U.S. have used PCSS and similar devices with favorable outcomes and a low device-related complication rate of 3.4%.¹

An implant similar to PCSS has been approved and used in Europe for many years.²

The company that designed PCSS conducted a clinical study in the Philippines using a similar implant placed into the same spinal joints.

This study demonstrated:^3,4

A decrease in pain
Lower Neck Disability Index (NDI) scores — a quality of life scale
High fusion rate

In a biomechanical study, the combination of ACDF (anterior fusion) and a PCF (posterior fusion) using PCSS significantly increased spinal stability versus ACDF alone.⁵

Request Study Brochure

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Learn more at www.fusestudy.com

For detailed information about this cervical fusion clinical study visit: clinicaltrials.gov

Before deciding to participate in the study, please discuss the risks and benefits of this study with your doctor.

CAUTION — PCSS is an investigational device. Limited by federal law to investigational use.

About Providence Medical Technology

Our Purpose is to improve clinical outcomes for high-risk patients and prevent surgical failures of the cervical spine.

Our Mission is to establish Circumferential Cervical Fusion (CCF) as the standard of care for high-risk patients.

4234 Hacienda Dr. Suite 150

Pleasanton, CA 94588

www.providencemt.com

References

1. Siemionow K, et al. (2017) J Craniovertebr Junction Spine.
2. Internal company records of Providence Medical Technology, Inc.
3. McCormack B, et al. (2013) J Neurosurg Spine.
4. Siemionow K, et al. (2016) J Neurol Surg A Cent Eur Neurosurg.

5. Voronov LI, et al. (2016) Medical Devices (Auckl).

Disclaimers

* PCSS is an investigational device. Limited by federal law to investigational use.

† Patients who agree to participate in the study are reimbursed for study travel expenses. Reimbursement details will be provided by your doctor.