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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Xi'an International Medical Center Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Spondylosis

Interventions

Type	Name	Description
PROCEDURE	mobile artificial cervical vertebrae replacement	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.
PROCEDURE	anterior cervical corpectomy and fusion	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.

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-11-01
• Completion: 2022-11-01
• First posted: 2021-03-24
• Last updated: 2021-04-12

Locations

1 site across 1 country: China