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Spinal Implant

PCSS Surgery for Degenerative Disc Disease (FUSE Trial)

N/A

Waitlist Available

Research Sponsored by Providence Medical Technology, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Indicated for ACDF treatment of degenerative disc disease (DDD) between and including C3-C7 at 3 contiguous levels

Reported to be medically cleared for surgery

Must not have

A concomitant condition requiring daily, high-dose oral and/or inhaled steroids

Diagnosis of Paget's disease, osteomalacia or any other metabolic bone disease other than osteoporosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study a new device to see if it's safe and effective in treating cervical degenerative disease.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include typical risks associated with spinal surgery such as pain at the site of surgery, infection risk, nerve damage that could lead to weakness or numbness, bleeding complications or reactions to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My doctor has approved me for surgery.

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I am between 18 and 80 years old.

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I am able and willing to follow the study's requirements and attend all scheduled visits.

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My condition did not improve with basic treatments like rest, heat, or painkillers.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need daily high-dose steroids.

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

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

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I have osteoporosis with a T-score of -2.5 or lower.

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I have a condition that prevents back fusion surgery.

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I have seizures that are not controlled by medication.

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I have not had, nor do I plan to have treatment for an active infection like HIV or Hepatitis C.

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My spine condition is severe and diagnosed as spondylolisthesis.

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I have a birth defect in my bones or spinal cord that affects my spine's stability.

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I have been using opioids long-term, not exceeding 120 mg of morphine daily.

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I do not have any ongoing infections.

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I have had spine surgery or a false joint at the level of my current operation.

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I have a permanent nerve problem that surgery cannot fix.

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I have had a serious neck injury that could interfere with medical device placement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Superiority in Fusion Success in CCF (treatment) compared to ACDF (control)

Secondary study objectives

Non-inferiority Composite Safety Success in CCF (treatment) compared to ACDF (control)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 19Eligibility criteria met