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Spinal Implant
Synergy Disc vs. ACDF Surgery for Degenerative Disc Disease
N/A
Recruiting
Research Sponsored by Synergy Spine Solutions
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 week, 3 month, 6 month, 12 month, 24 month
Awards & highlights
Study Summary
This trial will compare the safety and effectiveness of Synergy Disc to traditional ACDF for treating cervical DDD in unresponsive patients. Results evaluated before & after surgery, & at 3, 6, 12 & 24 months. Primary analysis at 24 months.
Who is the study for?
This trial is for adults over 18 with neck pain and cervical degenerative disc disease at two adjacent levels from C3 to C7, who haven't improved with non-surgical treatments. They must have a specific level of disability and pain, documented nerve compression, no severe facet joint issues or certain metabolic disorders, no recent investigational therapy or spinal surgeries (with some exceptions), not be pregnant or planning pregnancy during the study.Check my eligibility
What is being tested?
The study is testing the Synergy Disc's safety and effectiveness compared to conventional anterior cervical discectomy and fusion (ACDF) surgery in treating cervical degenerative disc disease. Patients will be monitored before surgery and up to 24 months post-surgery to see if this new treatment works as well as the standard one.See study design
What are the potential side effects?
While side effects are not explicitly listed here, typical risks associated with spine surgery may include infection, nerve damage, blood clots, reactions to anesthesia, implant failure or movement, persistent pain at the bone graft site (for ACDF), difficulty swallowing or hoarseness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 week, 3 month, 6 month, 12 month, 24 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 week, 3 month, 6 month, 12 month, 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 Adverse Event
NDI
Secondary Surgical Intervention
+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 restore kinematics to the cervical spine. The Synergy Disc is intended for use in the cervical spine for reconstruction of the disc following a two level discectomy for intractable radiculopathy and/or myelopathy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anterior Cervical Discectomy and Fusion
2006
Completed Phase 3
~340
Find a Location
Who is running the clinical trial?
Synergy Spine SolutionsLead Sponsor
6 Previous Clinical Trials
575 Total Patients Enrolled
MCRAIndustry Sponsor
33 Previous Clinical Trials
9,166 Total Patients Enrolled
Jane M Jacob, PhDStudy DirectorSynergy Spine Solutions
3 Previous Clinical Trials
300 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cervical spine surgery before, except for certain types.I have a hormone or metabolism disorder that affects bone growth.I have severe joint issues in my spine.I need medication after surgery that may affect my implant's stability.I haven't had experimental treatments in the last 28 days and don't plan any for the next 16 weeks.I use insulin for my diabetes.I am not pregnant or nursing and agree not to become pregnant during the study.I have a herniated disc or bone spurs causing nerve or spinal cord compression, confirmed by tests.My bone density test shows I have severe osteoporosis.I have a cervical spine condition that needs surgery, not just degenerative disc disease.My cancer has spread to my spine.I have been diagnosed with instability in my neck.I currently have a bacterial infection.I only have neck pain without any arm pain or spinal cord symptoms.I have had kidney problems or kidney failure in the past.I am over 18 and my bones have stopped growing.I haven't taken any drugs that affect bone health in the last two weeks.My condition hasn't improved after 6 weeks of non-surgical treatment.I have been diagnosed with osteomalacia.I am not able to make decisions for myself.I have severe neck pain from disc disease needing surgery.I have a herniated disc or bone spurs causing pain and nerve issues, confirmed by scans.I need surgery for severe neck disc disease affecting my nerves or spinal cord.Your neck disability score is very high, which means you have significant problems with your neck function.
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.
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