- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04806360
Anterior Spinal Canal Reconstruction and Fusion Surgery for Treating Degenerative Cervical Kyphosis With Stenosis
May 4, 2022 updated by: Xuhua Lu, Shanghai Changzheng Hospital
Application of Anterior Spinal Canal Reconstruction and Fusion Surgery for Treating Degenerative Cervical Kyphosis With Stenosis:a Multicenter Randomized Controlled Trial
Degenerative cervical kyphosis with stenosis (DCKS) is a common cervical spine degenerative disease, causing pain, numbness, and weakness of limbs, which seriously affect the quality of life of the patient.
Surgery is an effective way to treat this condition, however, the best surgical procedure is still controversial.
Anterior spinal canal reconstruction and fusion surgery (ACRF) is a new surgical procedure that previously proposed by our team, it combines the advantages of both the conventional anterior and posterior approach.
The purpose of this study is to evaluate the safety and effectiveness of ACRF surgery for treating DCKS.
A multicenter prospective randomized controlled trial was designed.
Eligible patients will be randomly divided into three groups, including the ACRF group, the conventional anterior surgery group, and the conventional posterior surgery group.
Demographic data, surgery Information, and follow-up results will be collected and compared between groups.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xuhua Lu, M.D.
- Phone Number: +862181885793
- Email: xuhualu@hotmail.com
Study Contact Backup
- Name: Bangke Zhang, M.D.
- Phone Number: +8618301783716
- Email: zbk12345@163.com
Study Locations
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Shanghai, China, 200003
- Shanghai Changzheng Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients are diagnosed with degenerative cervical kyphosis with stenosis
- Patients aged between 30 and 70 years
- Patients meet the indications for surgery
- Patients submitted written informed consent
Exclusion Criteria:
- Tumor, infection, or trauma of the cervical spine
- Severe cervical kyphosis that greater than 50°
- Severe ossification of the posterior longitudinal ligament of the cervical spine
- Patients with ankylosing spondylitis
- Previous surgery of the cervical spine
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ACRF group
ACRF is a new surgical procedure that previously proposed by our team, it combines the advantages of both the conventional anterior and posterior approach.
Eligible patients in this group will receive ACRF surgery.
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A new surgical procedure that previously proposed by our team.
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Active Comparator: conventional anterior surgery group
Eligible patients in this group will receive conventional anterior surgery, including anterior cervical discectomy and fusion surgery or anterior cervical corpectomy and fusion surgery.
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Anterior cervical discectomy and fusion surgery or anterior cervical corpectomy and fusion surgery.
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Active Comparator: conventional posterior surgery group
Eligible patients in this group will receive conventional posterior surgery, including laminectomy and fusion surgery or laminoplasty surgery.
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Laminectomy and fusion surgery or laminoplasty surgery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Japanese Orthopaedic Association Score (JOA)
Time Frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
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Total score 0-17.
The lower the score the more severe the deficits.
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baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
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Change of Neck Disability Index (NDI)
Time Frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
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Ranging from 0%-100%.
A higher score indicates more patient-rated disability.
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baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
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Change of Sagittal Lordosis Angle
Time Frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
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Measured by lateral X-Ray image.
The change of lordosis was calculated and compared.
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baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
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Change of Cross-sectional area of the spinal canal
Time Frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
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Measured by MRI image.
The change of cross-sectional area of the spinal canal was calculated and compared.
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baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reoperation rate
Time Frame: 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
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Any reoperation involving the same segments or adjacent segments will be calculated.
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1 month, 3 months, 6 months, 12 months and 24 months post-treatment
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Change of Pain Scores on the Visual Analog Scale (VAS)
Time Frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
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Ranging from 0-10.
A higher score indicates more severe pain.
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baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
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Change of Range of Motion
Time Frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
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Measured by dynamic X-Ray image.
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baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
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Complication rate
Time Frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
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Any complications related to surgery will be recorded.
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baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Xuhua Lu, M.D., Shanghai Changzheng Hospotal
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 1, 2022
Primary Completion (Anticipated)
December 30, 2023
Study Completion (Anticipated)
December 30, 2023
Study Registration Dates
First Submitted
February 16, 2021
First Submitted That Met QC Criteria
March 18, 2021
First Posted (Actual)
March 19, 2021
Study Record Updates
Last Update Posted (Actual)
May 9, 2022
Last Update Submitted That Met QC Criteria
May 4, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020YLCYJ-Y09
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Degenerative Cervical Kyphosis With Stenosis
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Assistance Publique - Hôpitaux de ParisTerminatedCervical Degenerative Disc Disease | Kyphosis | Lumbar Degenerative Disc DiseaseFrance
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Mesoblast, Ltd.CompletedSpinal Stenosis | Cervical Degenerative Disc Disease | Degenerative SpondylolisthesisUnited States
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Mesoblast, Ltd.CompletedSpinal Stenosis | Cervical Degenerative Disc Disease | Degenerative SpondylolisthesisAustralia
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Technical University of MunichCharite University, Berlin, Germany; University Hospital, Geneva; Ludwig-Maximilians... and other collaboratorsUnknownCervical Disc Herniation | Degenerative Cervical Spinal Stenosis | Suspected Cervical Spine InstabilityGermany
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Istituto Ortopedico RizzoliActive, not recruitingAIS | Thoracic Kyphosis | Cervical AlignmentItaly
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Ceragem Clinical Inc.Not yet recruitingKyphosis | Cervical Kyphosis | Cervical Lordosis
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Seoul National University HospitalActive, not recruitingNeck Pain | Myelopathy Cervical | Ossification of Posterior Longitudinal Ligament | Cervical Spondylosis With Myelopathy | Kyphosis Post SurgicalKorea, Republic of
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NuVasiveCompletedCervical Degenerative Disc DisorderUnited States
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NuVasiveActive, not recruitingCervical Degenerative Disc DisorderUnited States
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