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Clinical Trials/CTRI/2025/12/099846
CTRI/2025/12/099846Not yet recruitingNot Applicable

Evaluation of Clinical Outcomes of Preserving Versus Sacrificing C2 and C7 Spinous Process Attachments in Patients Undergoing Cervical Laminectomy: A Retrospective Observational Study

Stavya Spine Hospital and Research Institute1 site in 1 country100 target enrollmentStarted: January 5, 2026Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
1. mJOA score for neurological outcome

Study Overview

Brief Summary

This retrospective observational study will be conducted in Stavya Spine Hospital and Research Institute, Ahmedabad enrolling 100 consecutive patients diagnosed with multilevel cervical stenosis and myelopathy requiring C3-C6 or C3-C7 laminectomy. Patients will be randomly allocated into two equal groups: Group A and Group B. Group A (n=50) underwent modified muscle-preserving laminectomy with preservation of semispinalis cervicis and nuchal ligament attachments at C2 and C7 spinous processes, while Group B (n=50) underwent conventional laminectomy with complete detachment of posterior muscle complex from C2 and C7. The study will include patients of 40-75 years of age with multilevel cervical stenosis (Greater or equal to 3 levels), preoperative modified Japanese Orthopedic Association (mJOA) scores of 8-14, and minimum 6 month follow up. Patients with previous cervical surgery, congenital anomalies, inflammatory arthropathies, cervical trauma, malignancy and patients with incomplete clinical and radiological records will be excluded from the study.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
40.00 Year(s) to 75.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •More than or equal to 3 levels of cervical spinal stenosis and myelopathy
  • •Preoperative and postoperative imaging available (MRI, CT, or X-rays).

Exclusion Criteria

  • •A documented history of prior cervical spine surgery Presence of congenital anomalies Inflammatory arthropathies History of cervical trauma History of histologically proven cervical spinal tumor Patients with less than 6 months follow up post operatively Patients with incomplete pre operative or post operative data.

Outcomes

Primary Outcomes

1. mJOA score for neurological outcome

Time Frame: Follow up visits at 3 months and 6 months

2. NDI score for functional disability

Time Frame: Follow up visits at 3 months and 6 months

3. VAS score for pain

Time Frame: Follow up visits at 3 months and 6 months

4. Operative parameters which included intra operative blood loss, operative time and post op complications

Time Frame: Follow up visits at 3 months and 6 months

Secondary Outcomes

  • NIL.(NIL.)

Investigators

Sponsor
Stavya Spine Hospital and Research Institute
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Bharat R Dave

Stavya Spine Hospital And Research Institute

Study Sites (1)

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