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

NCT05959980 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-01-30

No results posted yet for this 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

Conditions

  • Hirayama Disease

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • All India Institute of Medical Sciences

    lead OTHER

Principal Investigators

  • Deepti Vibha · AIIMS, New Delhi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2026-09-30
Completion
2026-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05959980 on ClinicalTrials.gov