Cervical SpondylosisNCT04813211
Effectiveness and Safety of Mobile Artificial Cervical Vertebrae Replacement for Patients With Cervical Spondylosis
A study testing mobile artificial cervical vertebrae replacement and anterior cervical corpectomy and fusion in people with Cervical Spondylosis, run by Xi'an International Medical Center Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cervical Spondylosis
- What is being tested?
- mobile artificial cervical vertebrae replacement and anterior cervical corpectomy and fusion
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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;
Who cannot join
- (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;
Show all 23Show fewer
- (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.
Trial locations and contacts
1 site in 1 country.
China1 site
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, 710100
Xijing He, MD, 8613909266195, xijing_h@vip.tom.com
Xijing He, MD
About this study
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
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.
Read the 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
- Being tested
- mobile artificial cervical vertebrae replacement, anterior cervical corpectomy and fusion
- Keywords
- cervical spondylosis, cervical spine, intervertebral disc, joint replacement
- Medical subject headings
- Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile artificial cervical vertebrae replacementProcedure or surgery
Also called Trial group
- 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.
anterior cervical corpectomy and fusionProcedure or surgery
Also called Control group
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Trial group | Experimental | 20 patients with cervical spondylosis undergoing mobile artificial cervical vertebrae replacement Receives: Procedure: mobile artificial cervical vertebrae replacement |
| Control group | Experimental | 20 patients with cervical spondylosis undergoing anterior cervical corpectomy and fusion Receives: Procedure: anterior cervical corpectomy and fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 °).
Measured: 6 months after operation
Secondary outcomes (7)
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).
Measured: 3 to 6 months after operation
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.
Measured: 3 to 6 months after operation
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
Measured: 7 days to 6 months after operation
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.
Measured: 7 days to 6 months after operation
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.
Measured: 7 days to 6 months after operation
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.
Measured: 7 days after operation
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.
Measured: 7 days to 6 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical SpondylosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two or more groups in parallel for the duration of the study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xi'an International Medical Center Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital of Xi'an Jiaotong University
- Responsible party
- Principal investigator, Qiang Yin, Xi'an International Medical Center Hospital
- Investigators
- Xijing He, MD, Principal investigator, Xi'an International Medical Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813211
- Sponsor's protocol ID
- XianInternationalMCH_HXJ_02
- Status last verified
- Apr 2021
- First submitted
- 17 Mar 2021
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04813211
- Acronym / sponsor ID
- XianInternationalMCH_HXJ_02
- Conditions
- Cervical Spondylosis
- Keywords
- cervical spondylosis, cervical spine, intervertebral disc, joint replacement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xi'an International Medical Center HospitalUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Xi'an Jiaotong University
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two or more groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Trial group | Experimental | Procedure: mobile artificial cervical vertebrae replacement20 patients with cervical spondylosis undergoing mobile artificial cervical vertebrae replacement |
| Control group | Experimental | Procedure: anterior cervical corpectomy and fusion20 patients with cervical spondylosis undergoing anterior cervical corpectomy and fusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- (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;
Key exclusion criteria (23 listed)
- (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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mobile artificial cervical vertebrae replacementAlso: Trial group1. 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 or surgery | Trial group |
| anterior cervical corpectomy and fusionAlso: Control group1. 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. | Procedure or surgery | Control group |
Primary outcome
Cervical joint range of motion at 6 months after operation
Time frame: 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 °).
7 secondary outcomes
Cervical fusion rate at 3 to 6 months after operation
Time frame: 3 to 6 months after operation
Cervical joint range of motion at 7 days to 3 months after operation
Time frame: 3 to 6 months after operation
Japanese Orthopaedic Association (JOA) scores at 7 days to 6 months after operation
Time frame: 7 days to 6 months after operation
Neck Disability Index (NDI) scores at 7 days to 6 months after operation
Time frame: 7 days to 6 months after operation
Visual analogue scale (VAS) scores at 7 days to 6 months after operation
Time frame: 7 days to 6 months after operation
CT images of the cervical spine at 7 days postoperatively
Time frame: 7 days after operation
X-ray of the cervical spine at 7 days to 6 months after operation
Time frame: 7 days to 6 months after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xijing He, MD principal investigator
Xi'an International Medical Center Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile artificial cervical vertebrae replacement and anterior cervical corpectomy and fusion in people with Cervical Spondylosis, run by Xi'an International Medical Center Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xijing He, MD (8613909266195, xijing_h@vip.tom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical joint range of motion at 6 months after operation (time frame: 6 months after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2021.