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

NCT04813211 | Unknown DMC

• 1 other identifier: XianInternationalMCH_HXJ_02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Spondylosis

Keywords

cervical spondylosis; cervical spine; intervertebral disc; joint replacement

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Cervical fusion rate at 3 to 6 months after operation

  3 to 6 months after operation

• Cervical joint range of motion at 7 days to 3 months after operation

  3 to 6 months after operation

• Japanese Orthopaedic Association (JOA) scores at 7 days to 6 months after operation

  7 days to 6 months after operation

• Neck Disability Index (NDI) scores at 7 days to 6 months after operation

  7 days to 6 months after operation

• Visual analogue scale (VAS) scores at 7 days to 6 months after operation

  7 days to 6 months after operation

Other Outcomes (1)

• The incidence of adverse events at 7 days to 6 months after operation.

  7 days to 6 months after operation

Study Arms (2)

Trial group

EXPERIMENTAL

20 patients with cervical spondylosis undergoing mobile artificial cervical vertebrae replacement

Procedure: mobile artificial cervical vertebrae replacement

Control group

EXPERIMENTAL

20 patients with cervical spondylosis undergoing anterior cervical corpectomy and fusion

Procedure: anterior cervical corpectomy and fusion

Interventions

mobile artificial cervical vertebrae replacement PROCEDURE

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.

Also known as: Trial group

Trial group

anterior cervical corpectomy and fusion PROCEDURE

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.

Also known as: Control group

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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;

You may not qualify if:

• (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;

Sponsors & Collaborators

• Xi'an International Medical Center Hospital: lead
• Second Affiliated Hospital of Xi'an Jiaotong University: collaborator

Study Sites (1)

Xi'an International Medical Center Hospital

Xi'an, Shaanxi, 710100, China

Location

MeSH Terms

Conditions

Spondylosis

Interventions

Gene Fusion; Control Groups

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Recombination, Genetic; Genetic Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Xijing He, MD

  Xi'an International Medical Center Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xijing He, MD

CONTACT

8613909266195; xijing_h@vip.tom.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Nonrandomized Trial: participants are expressly assigned to intervention groups through a non-random method, such as physician choice
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: Participants are assigned to one of two or more groups in parallel for the duration of the study

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 24, 2021
• Study Start: June 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: April 12, 2021

Record last verified: 2021-04

Locations

CN (1)