As very few studies were conducted in our region on this topic this study designed to assess role of instrumented and non-instrumented decompression of cervical spine disorders and to compare these modalities in terms of pain relief and recovery time with little more complication rate.
Design
Two-arm parallel group, single-blind randomised controlled trial. Randomisation is manual with lottery method using the concealed envelops. Randomisation sequence carried out at an external site before the procedure, after explaining the details of study and informed consent.
Settings and conduct
Department of Neurosurgery, Gambat Institute of Medical Sciences, Gambat, Pakistan from May 2023 to May 2024,
Participants/Inclusion and exclusion criteria
Patients of degenerative cervical disease were enrolled and detailed clinical examination and complete history of any previous medical illness and surgical interventions was obtained. Patients with failed conservative management plan, developed neurological deficits were included and patients with history of any cardiac disease, cervical radiculopathy from below 12 weeks, two level disease, neurological deficit of advance stage, diabetic patients with neuropathy, and unfit for general anesthesia were excluded.
Pain reduction, recovery rate, and complications in cervical degenerative diseases.
General information
Reason for update
Acronym
ACDF-NI
IRCT registration information
IRCT registration number:IRCT20241220064110N1
Registration date:2025-01-16, 1403/10/27
Registration timing:retrospective
Last update:2025-01-16, 1403/10/27
Update count:0
Registration date
2025-01-16, 1403/10/27
Registrant information
Name
Tahir Shahab
Name of organization / entity
Gambat Institute of Medical Sciences Gambat, Pakistan
Country
Pakistan
Phone
+92 332 2358385
Email address
dr.tahirshahab@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-01, 1402/02/11
Expected recruitment end date
2024-05-01, 1403/02/12
Actual recruitment start date
2023-05-01, 1402/02/11
Actual recruitment end date
2024-05-01, 1403/02/12
Trial completion date
2024-10-01, 1403/07/10
Scientific title
Comparing the Efficacy of Non-instrumented Versus Instrumented Fusion in Anterior Cervical Discectomy
Public title
Efficacy of Non-instrumented Versus Instrumented Fusion in Anterior Cervical Discectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18-65 years
of both genders
Patients of degenerative cervical disease
Patients with failed conservative management plan
Patients who developed neurological deficits
Exclusion criteria:
Patients with a history of any cardiac disease
Cervical radiculopathy from below 12 weeks
Patients with two-level disease
Patients who developed neurological deficits of advanced stage
Diabetic patients with neuropathy,
Patients unfit for general anesthesia
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
48
Actual sample size reached:
52
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization based on individual unit was done using a lottery method in a concealed envelop, mentioning the name of intervention group.
Blinding (investigator's opinion)
Single blinded
Blinding description
in this study, the only participants of study i.e patients were blinded only regarding which type of intervention they will receives. The investigators and care takers were fully aware about the intervention groups and provided upto the mark care.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Ethical Review Board, Gambat
Street address
Pir Abdul Qadir Shah Jeelani Institute of Medical Sciences, Gambat Station Road, Pakistan
City
Gambat
Postal code
66080
Approval date
2023-04-01, 1402/01/12
Ethics committee reference number
PAQSJIMS/GMC/ORIC/07
Health conditions studied
1
Description of health condition studied
Degenerative cervical disease
ICD-10 code
M50.30
ICD-10 code description
Other cervical disc degeneration, unspecified cervical region
Primary outcomes
1
Description
Pain Reduction
Timepoint
12 weeks after the intervention
Method of measurement
VAS score for pain
2
Description
Recovery Rate
Timepoint
12 weeks after the intervention
Method of measurement
Time of recovery
Secondary outcomes
1
Description
Length of hospital stay
Timepoint
hospital stay
Method of measurement
days of hospital stay
Intervention groups
1
Description
Anterior Cervical Dissectomy and fusion will serve as the Intervention group. After induction under general anesthesia, in a supine postion, a layer-by-layer blunt dissection will be performed. Discectomy was performed with loupe magnification to achieve precise surgical intervention. During surgery in cases of hypertrophy and OPLL posterior longitudinal ligament and dura matter were severed, foramina patency was assessed and stenosis was relieved with foraminotomy. Bone graft was placed with graft cage and anterior interlocking was done at specific positions. Plate positioning and sagittal alignment were confirmed intraoperatively using fluoroscopy.
Category
Treatment - Devices
2
Description
Anterior Cervical Dissectomy will serve as the Control group: After induction under general anesthesia, in a supine postion, a layer-by-layer blunt dissection will be performed. Only Discectomy will be performed with loupe magnification to achieve precise surgical intervention
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Pir Abdul Qadir Shah Jeelani Institute of Medical Sciences Gambat
Full name of responsible person
Tahir Shahab
Street address
Pir Abdul Qadir Shah Jeelani Institute of Medical Sciences, Gambat Station Road, Pakistan
City
Gambat
Postal code
66080
Phone
+92 332 2358385
Email
dr.tahirshahab@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Neurosurgery Department, Pir Abdul Qadir Shah Jeelani Institute of Medical Sciences Gambat,
Full name of responsible person
Tahir Shahab
Street address
Pir Abdul Qadir Shah Jeelani Institute of Medical Sciences, Gambat Station Road, Pakistan
City
Gambat
Postal code
66080
Phone
+92 332 2358385
Email
dr.tahirshahab@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Neurosurgery Department, Pir Abdul Qadir Shah Jeelani Institute of Medical Sciences Gambat,
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Neurosurgery Department, Pir Abdul Qadir Shah Jeelani Institute of Medical Sciences Gambat,
Full name of responsible person
Tahir Shahab
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurosurgery
Street address
Pir Abdul Qadir Shah Jeelani Institute of Medical Sciences, Gambat Station Road, Pakistan
City
Gambat
Province
Sindh
Postal code
66080
Phone
+92 332 2358385
Email
dr.tahirshahab@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Neurosurgery Department, Pir Abdul Qadir Shah Jeelani Institute of Medical Sciences Gambat,
Full name of responsible person
Tahir Shahab
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurosurgery
Street address
Pir Abdul Qadir Shah Jeelani Institute of Medical Sciences, Gambat Station Road, Pakistan
City
Gambat
Province
Sindh
Postal code
66080
Phone
+92 332 2358385
Email
dr.tahirshahab@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Neurosurgery Department, Pir Abdul Qadir Shah Jeelani Institute of Medical Sciences Gambat,
Full name of responsible person
Tahir Shahab
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurosurgery
Street address
Pir Abdul Qadir Shah Jeelani Institute of Medical Sciences, Gambat Station Road, Pakistan
City
Gambat
Province
Sindh
Postal code
66080
Phone
+92 332 2358385
Email
dr.tahirshahab@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Comparing the efficacy of non-instrumented versus instrumented fusion in anterior cervical discectomy; as soon as the study is completed, there is plan to a share the document as well as data
When the data will become available and for how long
Data will be available publicly forever
To whom data/document is available
To all the medical fraternity
Under which criteria data/document could be used
document can be used for similar studies, esp carrying out meta-analysis
From where data/document is obtainable
Data will be shared on demand via email, as well as from the publishers site
What processes are involved for a request to access data/document
Just a simple email will be required.
Comments
Comparing the efficacy of non-instrumented versus instrumented fusion in anterior cervical discectomy, this work has been done with great responsibility, dedication, and honesty. It will be a rich source of decision-making for neurosurgeons.