Effectiveness and Safety of Mobile Artificial Cervical Vertebrae Replacement for Patients With Ce… (NCT04813211) | Clinical Trial Compass
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Effectiveness and Safety of Mobile Artificial Cervical Vertebrae Replacement for Patients With Cervical Spondylosis
China40 participantsStarted 2021-06-01
Plain-language summary
The research team designed an artificial cervical joint prosthesis suitable for subtotal resection of the lower cervical vertebral body. Previous studies regarding cadaver and animal experiments have found that this artificial joint not only retains the normal range of physiological motion of the joint, but also has good stability. Preliminary studies have shown that the designed joints are sufficiently safe and stable. The titanium materials for joints have been verified for their toxicology in long-term clinical trials and have been monitored under relevant national testing agencies in China.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* (1)Age: 18-70 years, irrespective of sex;
* (2)For mobile artificial cervical vertebrae replacement, patients with cervical spondylosis who are planned to undergo anterior cervical corpectomy and resection of two adjacent intervertebral discs;
* (3)For anterior cervical corpectomy and fusion, patients with cervical spondylosis who are planned to undergo anterior cervical corpectomy and resection of two adjacent intervertebral discs;
Exclusion Criteria:
* (1) Patients who have participated in other clinical studies 3 months before the inception of the study;
* (2) Abnormalities in liver and kidney functions (aspartate aminotransferase, alanine aminotransferase, blood creatinine and urea nitrogen levels are 1.5 times higher than normal);
* (3) Obvious abnormalities in the blood system;
* (4) Abuse of drugs or ethanol;
* (5) Patients who have brain disorders, abnormal judging ability, or cannot cooperate with the observer;
* (6) Coronary heart disease or severe kidney disease;
* (7) Severe metabolic diseases and endocrine diseases that are out of drug control;
* (8) Pregnant and lactating women and couples who are about to become pregnant in the near future;
* (9) Severe lung diseases such as asthma and lung dysfunction;
* (10) Immunodeficiency;
* (11) Single-segment intervertebral disc herniation or compression;
* (12) 3 or more vertebral segments herniated or spinal cord compression due to ligament ossification;
* (13) Active infection (systemic or loc…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cervical joint range of motion at 6 months after operation
Timeframe: 6 months after operation
Trial details
NCT IDNCT04813211
SponsorXi'an International Medical Center Hospital