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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
FUSE Trial 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.Check my eligibility
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.See study design
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.
FUSE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need surgery for disc disease in my neck between C3 and C7.
Select...
My doctor has approved me for surgery.
Select...
I am between 18 and 80 years old.
Select...
I am able and willing to follow the study's requirements and attend all scheduled visits.
Select...
My condition did not improve with basic treatments like rest, heat, or painkillers.
FUSE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Superiority in Fusion Success in CCF (treatment) compared to ACDF (control)
Secondary outcome measures
Non-inferiority Composite Safety Success in CCF (treatment) compared to ACDF (control)
FUSE 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.
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Who is running the clinical trial?
Providence Medical Technology, Inc.Lead Sponsor
2 Previous Clinical Trials
Victoria SumnersStudy DirectorProvidence Medical Technology, Inc.
Matt JenkinsStudy DirectorProvidence Medical Technology, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need surgery for disc disease in my neck between C3 and C7.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.I have not used epidural steroids in the last 14 days.I have a condition that prevents back fusion surgery.I have seizures that are not controlled by medication.You are allergic to titanium (Ti).I have not had, nor do I plan to have treatment for an active infection like HIV or Hepatitis C.My spine condition is severe and diagnosed as spondylolisthesis.My doctor has approved me for surgery.I have a birth defect in my bones or spinal cord that affects my spine's stability.I have neck pain without any nerve pain that would require surgery.I have osteoporosis with a T-score of -2.5 or lower.You have a very high BMI, which means you are significantly overweight.You have a medical condition that would make it difficult for the doctors to accurately evaluate your health (such as a neuromuscular disorder).I have been cancer-free for 5 years, except for non-melanoma skin cancer.I have been using opioids long-term, not exceeding 120 mg of morphine daily.I do not have any ongoing infections.I have had spine surgery or a false joint at the level of my current operation.I have a permanent nerve problem that surgery cannot fix.I have had a serious neck injury that could interfere with medical device placement.I am between 18 and 80 years old.I am able and willing to follow the study's requirements and attend all scheduled visits.I haven't used any experimental drugs or devices in the last 30 days.My condition did not improve with basic treatments like rest, heat, or painkillers.
Research Study Groups:
This trial has the following groups:- Group 1: Anterior Cervical Discectomy and Fusion (ACDF)
- Group 2: Circumferential Cervical Fusion (CCF)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Degenerative Disc Disease Patient Testimony for trial: Trial Name: NCT04229017 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who are the ideal candidates for participating in this research?
"This trial seeks 330 participants between the age of 18 and 80 who have intervertebral disc degeneration. To qualify, applicants must demonstrate a Neck Disability Index (NDI) score of at least 15/50, be unresponsive to non-operative conservative treatments such as physical therapy or pain relievers, comprehend required forms and documents in addition to being willing and able to attend follow-up visits."
Answered by AI
Is enrollment currently available for this clinical experiment?
"Affirmative. According to information available on clinicaltrials.gov, this medical trial is currently seeking participants. The study was initially posted on March 18th 2020 and the most recent update occurred September 26th 2022; 330 patients are needed across 17 different sites."
Answered by AI
How pervasive is this research taking place across the city?
"Patients can enrol in this study at 17 different medical facilities, such as Atlantic Neurosurgical & Spine Specialists in Wilmington and Barrow Neurological Institute in Phoenix. Additionally, OrthoNorCal offers the trial to patients located within Los Gatos."
Answered by AI
Do people who are 40 years or older qualify for participation in this clinical experiment?
"This study is open to those aged 18 - 80 who meet the prerequisites for entry."
Answered by AI
How many individuals have been enrolled in this clinical research project?
"This clinical trial necessitates 330 participants that meet the established eligibility requirements. Providence Medical Technology, Inc., is overseeing this initiative and will be utilizing medical centres such as Atlantic Neurosurgical & Spine Specialists in Wilmington and Barrow Neurological Institute in Phoenix for recruitment."
Answered by AI
Who else is applying?
What state do they live in?
California
Oklahoma
North Carolina
How old are they?
65+
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
OrthoNorCal
Atlantic Neurosurgical & Spine Specialists
Baylor College of Medicine
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
Physical therapy and opioids, Celebrex are not helping. Pain is not letting me sleep.
PatientReceived 2+ prior treatments
I’ve had chronic back pain from degenerative discs for decades. PT, chiropractic, stem cell therapy, RF ablation and meds haven’t offered sustained relief.
PatientReceived no prior treatments
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