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

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Sep 2026 → Dec 2026
See other at-risk trials from All India Institute of Medical Sciences

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoints: details revised at 1 of 1 entry Show 7 more changesShow less
    • Enrollment closed, study ongoing
    • Primary completion pushed from Sep 2026 to Dec 2026
    • Study completion date: Dec 2026 to Jan 2027
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 1 of 3 entries
    • Study description expanded, about 12 words
    • Site details revised
  2. Start date changed from estimate of Oct 2023 to Oct 1, 2023v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  4. Site contact updated
    • Study description expanded, about 1 word
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT05959980
Lead Sponsor All India Institute of Medical Sciences
Conditions
(from sponsor)		 Hirayama Disease
Related terms Amyotrophy, monomelic
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov