Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
NCT05959980

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

Led by All India Institute of Medical Sciences · Updated on 2024-01-30

80

Participants Needed

1

Research Sites

165 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 60 years
  • Diagnosis of Hirayama disease with clinical evidence of wasting and weakness in one limb
  • Progressive or initially progressive followed by stationary course
  • No compressive lesion of the spinal cord
  • Disease duration of 4 years or less
  • Worsening of clinical symptoms in the past six months
Not Eligible

You will not qualify if you...

  • Refusal to consent for randomization
  • Unwillingness to attend follow-up visits at three and six months

AI-Screening

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Trial Site Locations

Total: 1 location

1

Deepti Vibha

New Delhi, National Capital Territory of Delhi, India, 110029

Actively Recruiting

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Research Team

D

Deepti Vibha

CONTACT

K

Kanwaljeet Garg

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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