Degenerative Cervical Kyphosis With Stenosis Clinical Trial
Official title:
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.
| Status | Not yet recruiting |
| Enrollment | 90 |
| Est. completion date | December 30, 2023 |
| Est. primary completion date | December 30, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 30 Years to 70 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Shanghai Changzheng Hospital | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Shanghai Changzheng Hospital | Hangzhou 903 Hospital, China, Naval Specialty Medical Center, China, The NO.72 Army Hospital of Huzhou, China |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | Reoperation rate | Any reoperation involving the same segments or adjacent segments will be calculated. | 1 month, 3 months, 6 months, 12 months and 24 months post-treatment | |
| Secondary | Change of Pain Scores on the Visual Analog Scale (VAS) | Ranging from 0-10. A higher score indicates more severe pain. | baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment | |
| Secondary | Change of Range of Motion | Measured by dynamic X-Ray image. | baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment | |
| Secondary | Complication rate | Any complications related to surgery will be recorded. | baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment |