- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04813211
Effectiveness and Safety of Mobile Artificial Cervical Vertebrae Replacement for Patients With Cervical Spondylosis
Effectiveness and Safety of Mobile Artificial Cervical Vertebrae Replacement for Patients With Cervical Spondylosis: Study Protocol for a Prospective, Non-randomized Controlled, Clinical Trial
Study Overview
Status
Conditions
Detailed Description
Artificial cervical disc technology has achieved certain clinical effects in the treatment of single-segment lesions of the lower cervical spine. However, simple artificial cervical disc replacement is only applicable for single-segment disc herniation, but not for two adjacent cervical segmental lesions, concurrent with vertebral hyperplasia and ossification of the posterior longitudinal ligament in the cervical spine. Traditional vertebral corpectomy and bone graft fusion can reduce the mobility of the cervical spine. Therefore, non-fusion fixation for such diseases has been a key issue to improve the efficacy of surgical treatments.
To this end, 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.
To serve clinical patients faster and ensure that the trial design is safe, this study is designed to observe the effectiveness and safety of mobile artificial cervical vertebrae replacement for patients with cervical spondylosis.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Xijing He, MD
- Phone Number: 8613909266195
- Email: xijing_h@vip.tom.com
Study Locations
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Shaanxi
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Xi'an, Shaanxi, China, 710100
- Xi'an International Medical Center Hospital
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Contact:
- Xijing He, MD
- Phone Number: 8613909266195
- Email: xijing_h@vip.tom.com
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Principal Investigator:
- Xijing He, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 local cervical spine) or a history of local cervical spine infection;
- (14) A history of anterior cervical surgery;
- (15) Patients with a need for posterior surgical treatments, with severe arthritis of the cervical spine joint process, and with spinal cord compression on the back;
- (16) Severe osteoporosis;
- (17) Cervical vertebra deformity;
- (18) A history of ossification of the posterior longitudinal ligament of the cervical spine, ankylosing spondylitis, and heterotopic ossification;
- (19) Severe cervical spine instability or trauma to the posterior structure of the cervical spine, and cervical spondylolisthesis;
- (20) Abnormal soft tissues anterior to the cervical spine (tracheal or esophageal malformations, and a history of radiotherapy), and obesity;
- (21) Allergy to prosthetic materials;
- (22) Patients who have tumors that cannot be completely resected and patients who are predicted to suffer prosthetic loosening during survival time;
- (23) Other contraindications for surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Trial group
20 patients with cervical spondylosis undergoing mobile artificial cervical vertebrae replacement
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Other Names:
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Experimental: Control group
20 patients with cervical spondylosis undergoing anterior cervical corpectomy and fusion
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cervical joint range of motion at 6 months after operation
Time Frame: 6 months after operation
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Testing methods for cervical joint mobility include: Cervical joint range of motion in all directions will be accurately obtained through an in vitro infrared measurement after artificial joint replacement (joint range in °).
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6 months after operation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cervical fusion rate at 3 to 6 months after operation
Time Frame: 3 to 6 months after operation
|
A successful fusion is assessed according to Brantigan and Steffee's imaging rating scale: Suspicious bone fusion: bone bridge formation in the entire fusion area with a density at least similar to postoperative data, and no light-transmitting band between the grafted bone and the vertebral body; Strong fusion: the fused bone in the fusion area is more mature and dense as shown on postoperative images. A sclerosis zone between the grafted bone and the vertebral body indicates the fusion, but there is no interface between the grafted bone and the vertebral body, and the mature bone trabecula forms a bone bridge. The bone spurs on the anterior side of the vertebral body will be absorbed, and the bone graft in the intervertebral space will move forward until the facet joints are fused. Fusion rate = (number of successfully fused patients/total number of patients) × 100% (Fusion rate in percentage). |
3 to 6 months after operation
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Cervical joint range of motion at 7 days to 3 months after operation
Time Frame: 3 to 6 months after operation
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Testing methods for cervical joint mobility include
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3 to 6 months after operation
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Japanese Orthopaedic Association (JOA) scores at 7 days to 6 months after operation
Time Frame: 7 days to 6 months after operation
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JOA scoring involves upper limb motor function (4 points), lower limb motor function (4 points), sensation (6 points) and bladder function (3 points).
The higher score indicates the better motor function
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7 days to 6 months after operation
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Neck Disability Index (NDI) scores at 7 days to 6 months after operation
Time Frame: 7 days to 6 months after operation
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NDI is mainly used for assessing cervical spine function.
The higher score indicates the severer cervical spine dysfunction.
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7 days to 6 months after operation
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Visual analogue scale (VAS) scores at 7 days to 6 months after operation
Time Frame: 7 days to 6 months after operation
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VAS is mainly used for pain assessment.
The higher score indicate the severer pain.
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7 days to 6 months after operation
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CT images of the cervical spine at 7 days postoperatively
Time Frame: 7 days after operation
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CT images of the cervical spine are used to evaluate the implantation of the artificial cervical joint.
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7 days after operation
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X-ray of the cervical spine at 7 days to 6 months after operation
Time Frame: 7 days to 6 months after operation
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X-ray of the cervical spine is used for evaluating the morphology of the implanted cervical joint morphology.
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7 days to 6 months after operation
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of adverse events at 7 days to 6 months after operation.
Time Frame: 7 days to 6 months after operation
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Adverse events include implant shedding, displacement, joint loosening, fracture, prolapse, infection, and heterotopic ossification.
The incidence of adverse events = (number of patients with adverse events/total number of patients)×100%.
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7 days to 6 months after operation
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Xijing He, MD, Xi'an International Medical Center Hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XianInternationalMCH_HXJ_02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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