Clinical trial NCT04813211: Effectiveness and Safety of Mobile Artificial Cervical Vertebrae Replacement for Patients With Cervical Spondylosis
Official title: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Spondylosis
Keywords: cervical spondylosis
cervical spine
intervertebral disc
joint replacement
Lead sponsor: Xi'an International Medical Center Hospital
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital of Xi'an Jiaotong University
First posted: 2021-03-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two or more groups in parallel for the duration of the study
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cervical joint range of motion at 6 months after operation
timeFrame: 6 months after operation
Secondary outcomes:
measure: Cervical fusion rate at 3 to 6 months after operation
timeFrame: 3 to 6 months after operation
measure: Cervical joint range of motion at 7 days to 3 months after operation
timeFrame: 3 to 6 months after operation
measure: Japanese Orthopaedic Association (JOA) scores at 7 days to 6 months after operation
timeFrame: 7 days to 6 months after operation
measure: Neck Disability Index (NDI) scores at 7 days to 6 months after operation
timeFrame: 7 days to 6 months after operation
measure: Visual analogue scale (VAS) scores at 7 days to 6 months after operation
timeFrame: 7 days to 6 months after operation
measure: CT images of the cervical spine at 7 days postoperatively
timeFrame: 7 days after operation
measure: X-ray of the cervical spine at 7 days to 6 months after operation
timeFrame: 7 days to 6 months after operation
Other outcomes:
measure: The incidence of adverse events at 7 days to 6 months after operation.
timeFrame: 7 days to 6 months after operation
Locations:
city: Xi'an
country: China
facility: Xi'an International Medical Center Hospital
state: Shaanxi
Study officials:
affiliation: Xi'an International Medical Center Hospital
name: Xijing He, MD
role: PRINCIPAL_INVESTIGATOR
References: