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Cervical Fixation Surgery Cervical Collar for Management of Hirayama Disease: A Randomized Study
Sponsor: All India Institute of Medical Sciences
Summary
The goal of this clinical trial\] is to compare cervical collar versus neck stabilization surgery in diagnosed patients of Hirayama disease who have been reporting worsening of problems in the past six months. The main question\[s\] it aims to answer are: • Is cervical stabilization surgery (Posterior cervical fixation) superior to conservative management in the form of cervical collar placement in patients with progressive Hirayama disease, observed at six months after intervention Participants will have equal chance to: * Undergo cervical fixation surgery * Cervical collar management The investigators will study and compare the efficacy of both treatments upto six months after intervention
Official title: Posterior Cervical Fixation Versus Long-term Cervical Collar for Management of Hirayama Disease: Prospective Randomized Open Blinded Endpoint (PROBE), Phase III Study
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2023-10-01
Completion Date
2026-12
Last Updated
2024-01-30
Healthy Volunteers
No
Conditions
Interventions
Posterior cervical fixation surgery
These patients will undergo posterior cervical fixation in the form of cervical lateral mass screw fixation in extension without decompression under general anesthesia.
Locations (1)
Deepti Vibha
New Delhi, National Capital Territory of Delhi, India