Anterior Spinal Canal Reconstruction and Fusion Surgery for Treating Degenerative Cervical Kyphosis With Stenosis
Application of Anterior Spinal Canal Reconstruction and Fusion Surgery for Treating Degenerative Cervical Kyphosis With Stenosis：a Multicenter Randomized Controlled Trial
1 other identifier
interventional
90
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2021
CompletedFirst Posted
Study publicly available on registry
March 19, 2021
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedMay 9, 2022
May 1, 2022
1.3 years
February 16, 2021
May 4, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
Change of Japanese Orthopaedic Association Score (JOA)
Total score 0-17. The lower the score the more severe the deficits.
baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Change of Neck Disability Index (NDI)
Ranging from 0%-100%. A higher score indicates more patient-rated disability.
baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Change of Sagittal Lordosis Angle
Measured by lateral X-Ray image. The change of lordosis was calculated and compared.
baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Change of Cross-sectional area of the spinal canal
Measured by MRI image. The change of cross-sectional area of the spinal canal was calculated and compared.
baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Secondary Outcomes (4)
Reoperation rate
1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Change of Pain Scores on the Visual Analog Scale (VAS)
baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Change of Range of Motion
baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Complication rate
baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Study Arms (3)
ACRF group
EXPERIMENTALACRF 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.
conventional anterior surgery group
ACTIVE COMPARATOREligible patients in this group will receive conventional anterior surgery, including anterior cervical discectomy and fusion surgery or anterior cervical corpectomy and fusion surgery.
conventional posterior surgery group
ACTIVE COMPARATOREligible patients in this group will receive conventional posterior surgery, including laminectomy and fusion surgery or laminoplasty surgery.
Interventions
Anterior cervical discectomy and fusion surgery or anterior cervical corpectomy and fusion surgery.
Laminectomy and fusion surgery or laminoplasty surgery.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Changzheng Hospitallead
- Naval Specialty Medical Center, Chinacollaborator
- The NO.72 Army Hospital of Huzhou, Chinacollaborator
- 903 Hospital of Chinese People's Liberation Armycollaborator
Study Sites (1)
Shanghai Changzheng Hospital
Shanghai, 200003, China
Study Officials
- PRINCIPAL INVESTIGATOR
Xuhua Lu, M.D.
Shanghai Changzheng Hospotal
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Traumatic Orthopaedic Department
Study Record Dates
First Submitted
February 16, 2021
First Posted
March 19, 2021
Study Start
September 1, 2022
Primary Completion
December 30, 2023
Study Completion
December 30, 2023
Last Updated
May 9, 2022
Record last verified: 2022-05