Degenerative Cervical Kyphosis With Stenosis
Conditions
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.
Interventions
PROCEDUREACRF surgery
A new surgical procedure that previously proposed by our team.
PROCEDUREconventional anterior surgery
Anterior cervical discectomy and fusion surgery or anterior cervical corpectomy and fusion surgery.
PROCEDUREconventional posterior surgery
Laminectomy and fusion surgery or laminoplasty surgery.
Sponsors
Naval Specialty Medical Center, China
The NO.72 Army Hospital of Huzhou, China
903 Hospital of Chinese People's Liberation Army
Shanghai Changzheng Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Cross-sectional area of the spinal canal | baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment | Measured by MRI image. The change of cross-sectional area of the spinal canal was calculated and compared. |
| Change of Japanese Orthopaedic Association Score (JOA) | baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment | Total score 0-17. The lower the score the more severe the deficits. |
| Change of Neck Disability Index (NDI) | baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment | Ranging from 0%-100%. A higher score indicates more patient-rated disability. |
| Change of Sagittal Lordosis Angle | baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment | Measured by lateral X-Ray image. The change of lordosis was calculated and compared. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reoperation rate | 1 month, 3 months, 6 months, 12 months and 24 months post-treatment | Any reoperation involving the same segments or adjacent segments will be calculated. |
| Change of Pain Scores on the Visual Analog Scale (VAS) | baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment | Ranging from 0-10. A higher score indicates more severe pain. |
| Change of Range of Motion | baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment | Measured by dynamic X-Ray image. |
| Complication rate | baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment | Any complications related to surgery will be recorded. |
Countries
China
Contacts
Primary ContactXuhua Lu, M.D.
Backup ContactBangke Zhang, M.D.
Outcome results
None listed