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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;

Must not have

Radiographic confirmation of severe facet joint disease or degeneration

Severe myelopathy to the extent that the patient is wheelchair bound

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 week, 3, 6, 12, and 24 month

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

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

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My X-rays show severe wear and tear in my spine joints.

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My spinal cord condition has confined me to a wheelchair.

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I have been diagnosed with osteoporosis.

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My spine has a curve greater than 11 degrees.

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I have an active cancer other than non-melanoma skin cancer.

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My symptoms are caused by my tumor.

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I have an infection where I had surgery.

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

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I have had cervical spine surgery, but not laminoforaminotomy or single-level anterior cervical fusion.

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I manage my severe diabetes with daily insulin.

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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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My spinal canal is narrower than 10 mm due to a birth defect.

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I have been diagnosed with arachnoiditis.

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I am currently having a severe mental health episode or physical symptoms without a known medical cause.

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I am using, or will use, a device to help my neck bones heal.

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I have, or expect to receive treatment for, an active infection.

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I have an autoimmune disorder affecting my muscles and joints.

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I have a bone condition like Paget's disease or osteomalacia.

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My BMI is over 40.

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I have more than one fixed spine segment in my neck.

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I have had a serious neck injury affecting my spine.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 week, 3, 6, 12, and 24 month for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Device Related AE

NDI

Neurological Assessment

+1 more

Secondary study objectives

BZ Score

Odom's Criteria

Patient Satisfaction

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial 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

0 / 32Eligibility criteria met