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Synergy Disc vs. ACDF Surgery for Degenerative Disc Disease
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.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Synergy Disc
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Is the research team still recruiting participants?
"Clinicaltrials.gov confirms that this research is no longer seeking participants, as it was first posted on June 1st 2023 and last modified on the 30th of the same month. While this trial has already completed its recruitment process, there are presently 74 other clinical trials recruiting patients for various treatments."
In how many healthcare facilities is this investigation being conducted?
"Presently, this medical trial is being conducted at 13 distinct centres. These sites are situated in Sarasota, Santa Monica and Steamboat Springs with the other ten scattered across the US. To decrease travel burdens associated with participation, it is suggested to select a location close to your residence."
What are the primary aims of this medical study?
"This medical trial, to be assessed over two years, is primarily aimed at evaluating the efficacy of Secondary Surgical Intervention. BZ Score (Bazaz Dysphagia Score relative to baseline), Odom's Criteria (results for investigational Synergy Disc vs control ACDF) and Patient Satisfaction Questionnaire will also be utilized as secondary metrics."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- DFW Center for Spinal Disorders: < 48 hours
Average response time
- < 2 Days
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