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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
A new surgical procedure that previously proposed by our team.
Anterior cervical discectomy and fusion surgery or anterior cervical corpectomy and fusion surgery.
Laminectomy and fusion surgery or laminoplasty surgery.
Shanghai Changzheng Hospital
Shanghai, China
Change of Japanese Orthopaedic Association Score (JOA)
Total score 0-17. The lower the score the more severe the deficits.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Reoperation rate
Any reoperation involving the same segments or adjacent segments will be calculated.
Time frame: 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Change of Pain Scores on the Visual Analog Scale (VAS)
Ranging from 0-10. A higher score indicates more severe pain.
Time frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Change of Range of Motion
Measured by dynamic X-Ray image.
Time frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Complication rate
Any complications related to surgery will be recorded.
Time frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
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