What is Clinical Research?
Clinical research is the process used to collect safety and effectiveness data for new medical devices. There are several steps of approval before a device can be sold in the commercial marketplace in the United Steps. The first step in device development begins with extensive laboratory research; if the laboratory research is successful, then the scientists send their data in to the FDA (Food and Drug Administration) for approval to continue testing and studying the device in humans.
When a clinical trial (or sometimes called a clinical study) is approved by FDA, testing can begin in humans. For medical device trials, there may be a smaller feasibility study phase followed by a larger, pivotal study in which many people use the device and data are collected. At the end of the trial, the data are analyzed and submitted to FDA for approval. Once approved by FDA, the device can be sold on the commercial market in the United States.
Every clinical trial has a study protocol that must be followed. This protocol outlines how each doctor, or clinical research scientist, will conduct the trial and includes the eligibility criteria for patient selection. By using standardized eligibility criteria (inclusion and exclusion criteria), the clinical researcher scientists can better understand the results.
Participation in the Synergy Disc trial, or in any clinical trial, requires a commitment from the patient to follow the rules of the trial and to return to your physician for all follow-up visits. This helps to ensure that the data collected in the study are of the highest quality.
While the Synergy Disc has been commercialized outside the United States, the Food and Drug Administration (FDA) requires that the safety and effectiveness of all medical devices be tested in the United States before being put on the US market.
Resources for Patients Interested in Clinical Trials
There are many resources available for patients interested in volunteering for a clinical trial. When considering participation in a clinical trial, it is important to make an informed decision. The links below will provide you with answers to general questions you may have about clinical trials as well as help you discuss your participation in a clinical trial with your physician.
The Synergy Disc Clinical Trial
The Synergy Disc clinical trial is a multicenter, non-randomized, historically controlled study designed to show that the Synergy Disc is at least as safe and effective as an Anterior Cervical Discectomy and Fusion (ACDF) procedure to treat a degenerated cervical disc at one level. All patients qualifying for participation in this clinical trial will receive the Synergy Disc.
Cervical degenerative disc disease (DDD) is a condition characterized by degenerated and/or diseased discs leading to nerve root and/or spinal cord compression in the cervical spine. The treatment continuum spans from conservative treatments and therapies to surgical procedures. While less prevalent than low back pain, cervical DDD is equally debilitating and requires careful clinical management to ensure patients return to a normal quality of life.
The Synergy Disc is a cervical disc prosthesis that can be inserted between C3-C7 in skeletally mature patients after cervical discectomy to provide restoration of motion and alignment to the functional spinal unit. 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.
There are 8 visits in the first two years of the study, all of them in the office. After the first two years, there may be additional annual follow up visits.
You will be asked to complete several patient questionnaires and answer questions about your general health and any medications you may be taking. The rest of the visits will be routine for this type of surgery.
There are no additional costs to you for participation in the study. Your insurance will pay for the routine care and Synergy Spine Solutions Ltd (the trial Sponsor) will pay for the rest of it. If you qualify to be in the study, you will be compensated for your time and travel.
To Qualify for the Study, You Must:
- Be between the ages of 18 and 70
- Have been diagnosed with DDD at one level in your neck
- Have not had a fusion surgery at this level before
- Not have osteoporosis or any bone disease (Paget’s, osteomalacia)
- Not have diabetes requiring daily insulin therapy
- Not have had an active cancer within the past 5 years except for skin cancers
- Be willing and able to complete all follow up visits
There are additional qualification requirements that will need to be met. Your doctor and the study coordinator will discuss these with you.
Additional Information on the Synergy Disc clinical trial can be found using the links below
All clinical trials are posted on the national website ClinicalTrials.gov
The link to the Synergy Disc clinical trial is (NCT 04469231), which has additional information on the study including the locations where the study is being done.