Ignite Creation Date:
2024-05-06 @ 7:16 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05959980
Status:
RECRUITING
Last Update Posted:
2024-01-30
First Post:
2023-07-18
Brief Title:
Cervical Fixation Surgery Cervical Collar for Management of Hirayama Disease A Randomized Study
Sponsor:
All India Institute of Medical Sciences New Delhi
Organization:
All India Institute of Medical Sciences New Delhi
Study Overview
Official Title:
Posterior Cervical Fixation Versus Long-term Cervical Collar for Management of Hirayama Disease Prospective Randomized Open Blinded Endpoint PROBE Phase III Study
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 questions 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
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
Detailed Description:
1 Study design
Prospective randomized open blinded endpoint PROBE phase III study
2 Inclusion criteria
All the following
1 Age 18 years
2 Patients with Hirayama disease as per the following criteria All of the following 16
1 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
2 Progressive course or initial progression followed by stationary course and
3 No evidence of a compressive lesion of the spinal cord
3 Disease duration of 4 years
4 Progression of clinical symptoms in the past six-months c Exclusion criteria
Any of the following
1 Refusal to consent for randomization 2 Not willing to come for three- and six-months follow-up e Procedures at baseline
1 Clinical electrophysiology and autonomic function assessments
After the clinical diagnosis by inclusion criteria the patients will undergo a detailed clinical examination as per the case record form CRF which includes power autonomic features grip strength and the objective assessment of the electrophysiological parameters
2 Radiological assessment
All patients will undergo MR imaging on a 15 T MR scanner Optima 450w General Electric Milwaukee USA using an 8-channel cervical-thoracic-lumbar array spine coil The imaging will include axial and sagittal T2-WIs and post-gadolinium T1C in flexion neutral and extension positions In addition DTI protocol will include sagittal and axial acquisition of cervical cord in neutral position MR-DTI data will process on a dedicated workstation Advantage Windows workstation GE Healthcare WI USA using commercially available software Functool 14301 GE HealthCare WI USA After co-registration of raw images to correct the motion and distortion artefacts the ADC and FA images will be generated The mean minimum and maximum values of FA and ADC will be recorded from region of maximum cord compression T2-hyperintensity
The investogators will get a cervical spine radiograph at the time of discharge and at 6 months
3 Surgical procedure
The patients who are randomized to undergo posterior cervical fixation will be admitted in Neurosciences Centre All India Institute of Medical Sciences New Delhi These patients will undergo routine preoperative work up including routine blood investigations and a detailed preanesthetic checkup PAC These patients will undergo posterior cervical fixation in the form of cervical lateral mass screw fixation in extension without decompression under general anesthesia
Prospective randomized open blinded endpoint PROBE phase III study
2 Inclusion criteria
All the following
1 Age 18 years
2 Patients with Hirayama disease as per the following criteria All of the following 16
1 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
2 Progressive course or initial progression followed by stationary course and
3 No evidence of a compressive lesion of the spinal cord
3 Disease duration of 4 years
4 Progression of clinical symptoms in the past six-months c Exclusion criteria
Any of the following
1 Refusal to consent for randomization 2 Not willing to come for three- and six-months follow-up e Procedures at baseline
1 Clinical electrophysiology and autonomic function assessments
After the clinical diagnosis by inclusion criteria the patients will undergo a detailed clinical examination as per the case record form CRF which includes power autonomic features grip strength and the objective assessment of the electrophysiological parameters
2 Radiological assessment
All patients will undergo MR imaging on a 15 T MR scanner Optima 450w General Electric Milwaukee USA using an 8-channel cervical-thoracic-lumbar array spine coil The imaging will include axial and sagittal T2-WIs and post-gadolinium T1C in flexion neutral and extension positions In addition DTI protocol will include sagittal and axial acquisition of cervical cord in neutral position MR-DTI data will process on a dedicated workstation Advantage Windows workstation GE Healthcare WI USA using commercially available software Functool 14301 GE HealthCare WI USA After co-registration of raw images to correct the motion and distortion artefacts the ADC and FA images will be generated The mean minimum and maximum values of FA and ADC will be recorded from region of maximum cord compression T2-hyperintensity
The investogators will get a cervical spine radiograph at the time of discharge and at 6 months
3 Surgical procedure
The patients who are randomized to undergo posterior cervical fixation will be admitted in Neurosciences Centre All India Institute of Medical Sciences New Delhi These patients will undergo routine preoperative work up including routine blood investigations and a detailed preanesthetic checkup PAC These patients will undergo posterior cervical fixation in the form of cervical lateral mass screw fixation in extension without decompression under general anesthesia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None