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

Primary Purpose

Cervical Spondylosis

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

mobile artificial cervical vertebrae replacement

anterior cervical corpectomy and fusion

About this trial

This is an interventional treatment trial for Cervical Spondylosis focused on measuring cervical spondylosis, cervical spine, intervertebral disc, joint replacement

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Xi'an International Medical Center Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Trial group

Control group

Arm Description

20 patients with cervical spondylosis undergoing mobile artificial cervical vertebrae replacement

20 patients with cervical spondylosis undergoing anterior cervical corpectomy and fusion

Outcomes

Primary Outcome Measures

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 °).

Secondary Outcome Measures

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).

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

Testing methods for cervical joint mobility include X-ray: The mobility of the cervical spine during flexion and extension, lateral flexion, and rotation; Coda Motion, an internationally advanced joint mobility measuring instrument of the experimental unit, will be used to measure cervical spine mobility; Cervical joint range of motion in all directions will be accurately obtained through an in vitro infrared measurement after artificial joint replacement.

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

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.

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.

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.

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.

Full Information

NCT ID

NCT04813211

First Posted

March 17, 2021

Last Updated

April 7, 2021

Sponsor

Xi'an International Medical Center Hospital

Collaborators

Second Affiliated Hospital of Xi'an Jiaotong University

1. Study Identification

Unique Protocol Identification Number

NCT04813211

Brief Title

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

Official Title

Effectiveness and Safety of Mobile Artificial Cervical Vertebrae Replacement for Patients With Cervical Spondylosis: Study Protocol for a Prospective, Non-randomized Controlled, Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2021 (Anticipated)

Primary Completion Date

November 1, 2022 (Anticipated)

Study Completion Date

November 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Xi'an International Medical Center Hospital

Collaborators

Second Affiliated Hospital of Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Spondylosis

Keywords

cervical spondylosis, cervical spine, intervertebral disc, joint replacement

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Masking Description

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

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Trial group

Arm Type

Experimental

Arm Description

20 patients with cervical spondylosis undergoing mobile artificial cervical vertebrae replacement

Arm Title

Control group

Arm Type

Experimental

Arm Description

20 patients with cervical spondylosis undergoing anterior cervical corpectomy and fusion

Intervention Type

Procedure

Intervention Name(s)

mobile artificial cervical vertebrae replacement

Other Intervention Name(s)

Trial group

Intervention Description

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. Anesthesia: General anesthesia via oral tracheal intubation. Surgical approach: Anterior cervical spine approach through the space between the visceral sheath and the vascular sheath. 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

Intervention Name(s)

anterior cervical corpectomy and fusion

Other Intervention Name(s)

Control group

Intervention Description

Position: The patient is in a supine position with the neck hyperextended. Anesthesia: General anesthesia via oral tracheal intubation. Surgical approach: Anterior cervical spine approach through the space between the visceral sheath and the vascular sheath. 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.

Primary Outcome Measure Information:

Title

Cervical joint range of motion at 6 months after operation

Description

Time Frame

6 months after operation

Secondary Outcome Measure Information:

Title

Cervical fusion rate at 3 to 6 months after operation

Description

Time Frame

3 to 6 months after operation

Title

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

Description

Time Frame

3 to 6 months after operation

Title

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

Description

Time Frame

7 days to 6 months after operation

Title

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

Description

NDI is mainly used for assessing cervical spine function. The higher score indicates the severer cervical spine dysfunction.

Time Frame

7 days to 6 months after operation

Title

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

Description

VAS is mainly used for pain assessment. The higher score indicate the severer pain.

Time Frame

7 days to 6 months after operation

Title

CT images of the cervical spine at 7 days postoperatively

Description

CT images of the cervical spine are used to evaluate the implantation of the artificial cervical joint.

Time Frame

7 days after operation

Title

X-ray of the cervical spine at 7 days to 6 months after operation

Description

X-ray of the cervical spine is used for evaluating the morphology of the implanted cervical joint morphology.

Time Frame

7 days to 6 months after operation

Other Pre-specified Outcome Measures:

Title

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

Description

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%.

Time Frame

7 days to 6 months after operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xijing He, MD

Phone

8613909266195

xijing_h@vip.tom.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xijing He, MD

Organizational Affiliation

Xi'an International Medical Center Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xi'an International Medical Center Hospital

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710100

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xijing He, MD

Phone

8613909266195

xijing_h@vip.tom.com

First Name & Middle Initial & Last Name & Degree

Xijing He, MD

12. IPD Sharing Statement

Learn more about this trial

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

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