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Artificial Disc Replacement
Synergy Disc vs ACDF Surgery for Degenerative Disc Disease
N/A
Waitlist Available
Research Sponsored by Synergy Disc Replacement Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Appropriate for treatment using an anterior surgical approach, including having no more than one previous anterior surgical approach to the cervical spine;
Age 18 70 years;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 week, 3, 6, 12, and 24 month
Awards & highlights
Study Summary
This trial will compare the Synergy Disc, a new device, to ACDF surgery, the current standard of care, to see if the new device is at least as safe and effective.
Who is the study for?
This trial is for adults aged 18-70 with cervical degenerative disc disease at one level from C3-C7, who haven't improved after six weeks of non-surgical treatment. Participants should have certain symptoms like arm pain or weakness and be able to follow the study's check-up schedule. People with previous major neck surgeries, multiple affected spinal levels, severe other diseases (like diabetes needing daily insulin), or pregnancy are excluded.Check my eligibility
What is being tested?
The study tests whether the Synergy Disc implant is as safe and effective as traditional surgery (ACDF) for treating single-level cervical degenerative disc disease unresponsive to conservative care. Patients will be monitored over two years with evaluations before surgery and several times postoperatively.See study design
What are the potential side effects?
Potential side effects may include typical surgical risks such as infection, pain at the site of operation, nerve damage, problems with the implant like loosening or breakage, difficulty swallowing, hoarseness, and possibly a need for additional surgeries.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am suitable for neck surgery from the front and have had no more than one such surgery before.
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I am between 18 and 70 years old.
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I have symptoms at only one level in my neck between C3 and C7.
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My scans show I have spinal degeneration.
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My condition hasn't improved with non-surgical treatments for 6 weeks, or my symptoms are getting worse.
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My condition hasn't improved after 6 weeks of non-surgical treatment or my symptoms are getting worse despite treatment.
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I have neck pain or arm pain, weakness, numbness, or unusual reflexes due to a spine condition.
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I have nerve pain or spinal cord issues in my neck affecting my arms or hands.
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I am between 18 and 70 years old.
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I have symptoms from a single spinal level between C3 and C7.
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I am a candidate for surgery from the front of my body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 week, 3, 6, 12, and 24 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 week, 3, 6, 12, and 24 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Device Related AE
NDI
Neurological Assessment
+1 moreSecondary outcome measures
BZ Score
Odom's Criteria
Patient Satisfaction
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Synergy DiscExperimental Treatment1 Intervention
The Synergy Disc is a cervical disc prosthesis that can be inserted between C3-C7 in skeletally mature patients after anterior discectomy to provide restoration of motion to the functional spinal unit. The Synergy Disc is designed to restoring kinematics to the cervical spine. The Synergy Disc is intended for use in the cervical spine for reconstruction of the disc following a single level discectomy for intractable radiculopathy and/or myelopathy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anterior Cervical Discectomy & Fusion
2015
N/A
~150
Find a Location
Who is running the clinical trial?
MCRAIndustry Sponsor
29 Previous Clinical Trials
8,981 Total Patients Enrolled
Synergy Disc Replacement LtdLead Sponsor
MCRA, LLCIndustry Sponsor
18 Previous Clinical Trials
7,548 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My X-rays show severe wear and tear in my spine joints.My condition hasn't improved after 6 weeks of non-surgical treatment, or my symptoms are getting worse despite treatment.I am suitable for neck surgery from the front and have had no more than one such surgery before.My spinal cord condition has confined me to a wheelchair.I am between 18 and 70 years old.I have been diagnosed with osteoporosis.My spine has a curve greater than 11 degrees.I am likely to develop joint problems within 6 months after my neck surgery.I have an active cancer other than non-melanoma skin cancer.I have symptoms at only one level in my neck between C3 and C7.My scans show I have spinal degeneration.My condition hasn't improved with non-surgical treatments for 6 weeks, or my symptoms are getting worse.My symptoms are caused by my tumor.I have an infection where I had surgery.The text is about a person who has a disc herniation on a CT or MRI scan.I have severe neck pain due to disc or bone problems in my neck.My condition hasn't improved after 6 weeks of non-surgical treatment or my symptoms are getting worse despite treatment.I have had cervical spine surgery, but not laminoforaminotomy or single-level anterior cervical fusion.I manage my severe diabetes with daily insulin.You are allergic to cobalt, chromium, molybdenum, titanium, or polyethylene.Your neck disability score is very high, with a score of 30 or more out of 100.I have a birth defect in my bones or spinal cord that affects my spine's stability.My spinal canal is narrower than 10 mm due to a birth defect.My doctor expects my spine condition to worsen within 6 months after neck surgery.I do not have any health issues that would interfere with this study's evaluations.I have neck pain or arm pain, weakness, numbness, or unusual reflexes due to a spine condition.Eagerness to comply with therapy and follow-up instructions.I have been diagnosed with arachnoiditis.I am currently having a severe mental health episode or physical symptoms without a known medical cause.I am using, or will use, a device to help my neck bones heal.I have, or expect to receive treatment for, an active infection.I am not taking medications that could affect bone or tissue healing.I have an autoimmune disorder affecting my muscles and joints.I have nerve pain or spinal cord issues in my neck affecting my arms or hands.I have neck pain without any nerve pain or spinal cord issues.I have a bone condition like Paget's disease or osteomalacia.You have severe neck disability, with a score of 30 or higher on the Neck Disability Index.My BMI is over 40.You have been using drugs or alcohol recently or in the past.I am between 18 and 70 years old.I have more than one fixed spine segment in my neck.I have had a serious neck injury affecting my spine.I have symptoms from a single spinal level between C3 and C7.I haven't used any experimental drugs or devices in the last 30 days.I am a candidate for surgery from the front of my body.Decreased disc height compared to adjacent levels on radiographic film, CT, or MRI.
Research Study Groups:
This trial has the following groups:- Group 1: Synergy Disc
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.
Cervical Disc Degeneration Patient Testimony for trial: Trial Name: NCT04469231 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the main aims of this clinical experiment?
"Per the clinical trial's sponsor, Synergy Disc Replacement Ltd., Neurological Assessment will be the main metric measured over a 2 year span. Moreover, at baseline and each subsequent follow-up point, Bazaz Dysphagia Score (BZ Score), Health Survey (SF-3) results, along with Odom's Criteria outcomes for both investigational Synergy Discs and ACDF controls are also to be assessed."
Answered by AI
What is the maximum capacity for this medical trial?
"This research study requires 190 eligible subjects to complete the trial. Potential participants have numerous locations where they can register, including Atlantic Brain & Spine in Reston, Virginia and Indiana Spine Group in Carmel, Indiana."
Answered by AI
What criteria must one satisfy to qualify for participation in this clinical trial?
"This clinical trial seeks to recruit up to 190 candidates with intervertebral disc degeneration and an age between 18 and 70."
Answered by AI
How many locations are currently hosting this randomized trial?
"This study has been launched in 20 distinct locations, such as Atlantic Brain & Spine (Reston), Indiana Spine Group (Carmel) and South carolina Sports Medicine & Orthopaedic Centre (North Charleston)."
Answered by AI
Are senior citizens being included in the recruitment process of this trial?
"The prerequisites for joining this clinical trial dictate that the minimum age is 18 and the maximum permissible age is 70."
Answered by AI
Are new participants being enlisted for this experiment at present?
"It is accurate, according to clinicaltrials.gov's information, that this medical trial is still seeking participants. Its first posting was on October 30th 2020 and its most recent update occurred on October 5th 2022. The study requires 190 patients from 20 different healthcare sites across the country."
Answered by AI
Who else is applying?
What state do they live in?
Other
California
Ohio
Colorado
What site did they apply to?
Anschutz Medical Center
Central Texas Brain & Spine
Orthopedic Specialty Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
Had cervical fusion, c5 c7. Still other discs to be worked on. No meds worked or injection, I'm open to trials to see if can improve my spine.
PatientReceived no prior treatments
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