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| Name | Class |
|---|---|
| Second Affiliated Hospital of Xi'an Jiaotong University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trial group | Experimental | 20 patients with cervical spondylosis undergoing mobile artificial cervical vertebrae replacement |
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| Control group | Experimental | 20 patients with cervical spondylosis undergoing anterior cervical corpectomy and fusion |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mobile artificial cervical vertebrae replacement | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 °). | 6 months after operation |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse events at 7 days to 6 months after operation. | 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%. | 7 days to 6 months after operation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xijing He, MD | Contact | 8613909266195 | xijing_h@vip.tom.com |
| Name | Affiliation | Role |
|---|---|---|
| Xijing He, MD | Xi'an International Medical Center Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xi'an International Medical Center Hospital | Xi'an | Shaanxi | 710100 | China |
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Participants are assigned to one of two or more groups in parallel for the duration of the study
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Nonrandomized Trial: participants are expressly assigned to intervention groups through a non-random method, such as physician choice
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| anterior cervical corpectomy and fusion | Procedure |
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| 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
| 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 | 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. | 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. | 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. | 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. | 7 days to 6 months after operation |
| ID | Term |
|---|---|
| D055009 | Spondylosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D050939 | Gene Fusion |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D011995 | Recombination, Genetic |
| D055614 | Genetic Phenomena |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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