Posterior Cervical Fixation Versus Long-term Cervical Collar for Management of Hirayama Disease: Prospective Randomized Open Blinded Endpoint (PROBE), Phase III Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• All the following:

‣ Age ≥ 18 years

⁃ Patients with Hirayama disease as per the following criteria (All of the following) (16):

• 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)

∙ Progressive course, or initial progression followed by stationary course; and

∙ No evidence of a compressive lesion of the spinal cord.

⁃ Disease duration of ≤4 years

⁃ Progression of clinical symptoms in the past six-months

Locations
Other Locations
India
Deepti Vibha
RECRUITING
New Delhi
Contact Information
Primary
Deepti Vibha
deeptivibha@aiims.edu
+91-011-26594485
Backup
Kanwaljeet Garg
kanwaljeet@aiims.edu
+91-968569905
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 80
Treatments
Experimental: Surgical arm
Will undergo posterior cervical fixation surgery within 4 weeks of randomization
No_intervention: Cervical collar arm
Will be given cervical collar for regular use
Related Therapeutic Areas
Sponsors
Leads: All India Institute of Medical Sciences

This content was sourced from clinicaltrials.gov

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