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Effectiveness and Safety of Mobile Artificial Cervical Vertebrae Replacement for Patients With Cervical Spondylosis

NCT04813211 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-04-12

No results posted yet for this study

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.

Conditions

  • Cervical Spondylosis

Interventions

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.

Sponsors & Collaborators

  • Second Affiliated Hospital of Xi'an Jiaotong University

    collaborator OTHER

  • Xi'an International Medical Center Hospital

    lead OTHER

Principal Investigators

  • Xijing He, MD · Xi'an International Medical Center Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2022-11-01
Completion
2022-11-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04813211 on ClinicalTrials.gov