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.
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
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
1. Position: The patient is in a supine position with the neck hyperextended, ensuring his/her neck and shoulders in a stable and neutral position before surgery and the cervical spine in a "physiological" curvature position. 2. Anesthesia: General anesthesia via oral tracheal intubation. 3. Surgical approach: Anterior cervical spine approach through the space between the visceral sheath and the vascular sheath. 4. Surgical method: Two intervertebral discs with adjacent lesions and part of the vertebral body between them will be removed. A curette is used to carefully strike off the annulus fibrosus and cartilage on the surface of the adjacent upper and lower endplates. Intraoperatively, the midlines of the segment and the vertebra to be replaced should be mapped out. When decompression, the midline for decompression should not be deviated from the planned midlines.
1. Position: The patient is in a supine position with the neck hyperextended. 2. Anesthesia: General anesthesia via oral tracheal intubation. 3. Surgical approach: Anterior cervical spine approach through the space between the visceral sheath and the vascular sheath. 4. Surgical method: Two intervertebral discs with adjacent lesions and part of the vertebrae between them will be removed. A curette will be used to carefully strike off the annulus fibrosus and cartilage on the surface of the adjacent upper and lower endplates. The removed vertebral bone will be trimmed into cancellous bone particles and filled in a cervical titanium cage with an appropriate size. The titanium cage will be implanted into the vertebral space, and fixed with adjacent vertebrae using anterior cervical titanium plates and screws.
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, China
Cervical joint range of motion at 6 months after operation
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 °).
Time frame: 6 months after operation
Cervical fusion rate at 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).
Time frame: 3 to 6 months after operation
Cervical joint range of motion at 7 days to 3 months after operation
Testing methods for cervical joint mobility include 1. X-ray: The mobility of the cervical spine during flexion and extension, lateral flexion, and rotation; 2. Coda Motion, an internationally advanced joint mobility measuring instrument of the experimental unit, will be used to measure cervical spine mobility; 3. Cervical joint range of motion in all directions will be accurately obtained through an in vitro infrared measurement after artificial joint replacement.
Time frame: 3 to 6 months after operation
Japanese Orthopaedic Association (JOA) scores at 7 days to 6 months after operation
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
Time frame: 7 days to 6 months after operation
Neck Disability Index (NDI) scores at 7 days to 6 months after operation
NDI is mainly used for assessing cervical spine function. The higher score indicates the severer cervical spine dysfunction.
Time frame: 7 days to 6 months after operation
Visual analogue scale (VAS) scores at 7 days to 6 months after operation
VAS is mainly used for pain assessment. The higher score indicate the severer pain.
Time frame: 7 days to 6 months after operation
CT images of the cervical spine at 7 days postoperatively
CT images of the cervical spine are used to evaluate the implantation of the artificial cervical joint.
Time frame: 7 days after operation
X-ray of the cervical spine at 7 days to 6 months after operation
X-ray of the cervical spine is used for evaluating the morphology of the implanted cervical joint morphology.
Time frame: 7 days to 6 months after operation
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