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A study to check if not cutting certain neck muscles during surgery improves recovery

Does Preservation of C2 and C7 Spinous Process Attachments Improve Patient Outcomes in Cervical Laminectomy? A Prospective Observational Study - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/12/098987
Enrollment
200
Registered
2025-12-11
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M480- Spinal stenosis

Interventions

Sponsors

Stavya Spine Hospital and Research Institute
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactDr Bharat R Dave

Stavya Spine Hospital And Research Institute

brd_172@yahoo.com09825019913

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026