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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAll India Institute of Medical Sciences

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

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.

Disqualifiers

Refusal to consent for randomization

Not willing to come for three- and six-months follow-up

Trial design

Design model

Parallel

Treatments tested in this trial

  • Posterior cervical fixation surgery

    Procedure/Surgery

    These patients will undergo posterior cervical fixation in the form of cervical lateral mass screw fixation in extension without decompression under general anesthesia.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Surgical armExperimental treatment 1 intervention
Group B: Cervical collar armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Odom's criteria score at six months

Time frame
Six months after intervention

Secondary outcomes

1

Odom's criteria score at three months

Time frame
Three months after intervention
2

interval change in DTI metrics of fractional anisotropy (FA) and apparent diffusion coefficient (ADC) of cervical cord

Time frame
at six-months post-intervention
3

Electrophysiological and grip strength

Time frame
6 month

Other outcomes

Sponsors and contacts

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