Health Condition 1: M480- Spinal stenosis
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Multilevel cervical stenosis involving greater or equal to 3 consecutive levels 2. Symptomatic cervical myelopathy with clinical and radiological correlation
Exclusion criteria
Exclusion criteria: 1. Documented history of prior cervical spine surgery. 2. Congenital spinal anomalies. 3. Individuals with inflammatory arthropathies. 4. Individuals with a history of traumatic injury to the cervical spine. 5. Individuals with significant comorbidities that may interfere with treatment outcomes (e.g., severe osteoporosis, malignancies, or systemic inflammatory disorders). 6. Ossification of Posterior Longitudinal Ligament (OPLL) extending beyond C2 and/or C7. 7. Inability to comply with the follow up schedule. 8. Pathology extending beyond C2 and/or C7
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mJOA scores (0-18): Assessed preoperatively and at 3, 6, 12, and 24 months postoperatively. JOA recovery rate calculated using: Recovery Rate (%) = [(Postoperative JOA - Preoperative JOA) / (17 - Preoperative JOA)] 100. Visual Analogue Scale (VAS) for axial neck pain : Measured at all time points, with 0 indicating no pain and 10 indicating worst imaginable pain. Neck Disability Index (NDI) (0-50 scale or percentage): Assessed at all time points, evaluating functional disability related to neck pain. Cervical Range of Motion (ROM) (degrees): Measured on dynamic lateral radiographs at 12 postoperatively. Timepoint: Follow up visits at 3 months, 6 months and 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| C2-C7 Cobb angle (degrees): Measured on lateral cervical radiographs at preoperative baseline & 12 months postoperatively. C2-C7 sagittal vertical axis (SVA) (mm): Measured on lateral cervical radiographs at baseline & 12 months. Cervical lordosis maintenance: Assessed by comparing preoperative & postoperative Cobb angles. Postoperative muscle cross-sectional area: Measured on T2-weighted MRI at 12 months comparing multifidus & semispinalis cervicis areas between groups. Timepoint: Follow up visits at 3 months, 6 months & 1 year | — |
Countries
India
Contacts
Stavya Spine Hospital And Research Institute