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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-11-01

Brief Summary

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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.

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Detailed Description

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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

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Cervical Spondylosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Nonrandomized Trial: participants are expressly assigned to intervention groups through a non-random method, such as physician choice

Study Groups

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Trial group

20 patients with cervical spondylosis undergoing mobile artificial cervical vertebrae replacement

Group Type EXPERIMENTAL

mobile artificial cervical vertebrae replacement

Intervention Type 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.

Control group

20 patients with cervical spondylosis undergoing anterior cervical corpectomy and fusion

Group Type EXPERIMENTAL

anterior cervical corpectomy and fusion

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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Trial group Control group

Eligibility Criteria

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Inclusion Criteria

* (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;

Exclusion Criteria

* (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;
* (16) Severe osteoporosis;
* (17) Cervical vertebra deformity;
* (18) A history of ossification of the posterior longitudinal ligament of the cervical spine, ankylosing spondylitis, and heterotopic ossification;
* (19) Severe cervical spine instability or trauma to the posterior structure of the cervical spine, and cervical spondylolisthesis;
* (20) Abnormal soft tissues anterior to the cervical spine (tracheal or esophageal malformations, and a history of radiotherapy), and obesity;
* (21) Allergy to prosthetic materials;
* (22) Patients who have tumors that cannot be completely resected and patients who are predicted to suffer prosthetic loosening during survival time;
* (23) Other contraindications for surgery.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No