Cervical Fixation Surgery Cervical Collar for Management of Hirayama Disease: A Randomized Study

NCT05959980 · tracked via the Priya Life Science India tracker

Sponsor

All India Institute of Medical Sciences

Phase

Not applicable

Started

2023-10-01

Last updated

2024-01-30

Condition(s) studied

Hirayama Disease

Investigational drug(s) / intervention(s)

Posterior cervical fixation surgery

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.

Study 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

Eligibility

Sex

ALL

Min age

18 Years

Max age

60 Years

Healthy volunteers

Inclusion Criteria: * All the following: 1. Age ≥ 18 years 2. Patients with Hirayama disease as per the following criteria (All of the following) (16): 1. Clinical evidence of wasting and weakness confined to one limb (EMG evidence of denervation in the opposite limb will not be a reason for exclusion) 2. Progressive course, or initial progression followed by stationary course; and 3. No evidence of a compressive lesion of the spinal cord. 3. Disease duration of ≤4 years 4. Progression of clinical symptoms in the past six-months Exclusion Criteria: * Any of the following: 1. Refusal to consent for randomization 2. Not willing to come for three- and six-months follow-up

Primary outcome measure(s)

Odom's criteria score at six months — Six months after intervention

Trial sites (1)

Facility	City	Region	Status
Deepti Vibha	New Delhi	National Capital Territory of Delhi	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05959980 on ClinicalTrials.gov ↗ ← All trials in India