A genetic study to evaluate the roles of interest genes in the pathogenesis of cervical intervertebral disc degeneration.
- Conditions
- Health Condition 1: M471- Other spondylosis with myelopathyHealth Condition 2: M483- Traumatic spondylopathy
- Registration Number
- CTRI/2021/02/031078
- Lead Sponsor
- Dr Vishal Kumar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
The diagnosis of CSM is based on clinical assessment and Magnetic
Resonance Imaging (MRI) findings, which is a standard tool for radiological evaluation of
CSM patients. There is an increase in signal intensity on T2 weighted images on MRI in the
region of cord compression and a decrease in signal intensity on T1 weighted images in
regions having Myelomalacia (loss of neural tissue).
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Patients with CSM presenting to the hospital, who need surgical treatment by anterior
approach will be assessed for eligibility and recruited in the study If they fulfill the following
inclusion criteria:
1. Patient of age >18 yrs. (of either sex).
2. Patients with symptomatic CSM.
3. Patients with GCS 15/15.
4. Patient willing/giving consent and fit in pre-anaesthetic checkup
5. Patient willing/giving written informed consent to take part in the study.
Patients will be excluded if any one of the following is present:
1. Prior cervical spine surgery
2. Myelopathy due to non-degenerative cause
3. Kyphotic alignment of cervical spine or straightened cervical curve
4. History of severe bleeding, coagulopathy, thrombocytopenia or other medically unfit
condition.
5. Patients intubated/ sedated prior to neurological examination
6. Patients planning for their pregnancy or already pregnant during the study.
7. Patients with any relative or absolute contraindications for surgery.
Patients will be assessed and recruited in the orthopaedics OPD in PGIMER. General health
check up and a neurological examination will be performed for each subject. This
examination will include a general physical examination, lab tests (Hb, TLC, platelet count,
PT, PTI, INR, aPTT, serum electrolytes, renal function tests), resting ECG and chest X-ray.
Screening for markers for HIV, HBsAg and HCV will be done prior to surgery. For HIV
screening HIV consent form will be signed from the participant and report will be kept
confidential. No patient will be excluded on the basis of the results of these triple test
markers. A detailed history will be taken to see for any incipent disease to prevent its
aggravation.
Patients presenting with acute traumatic cervical spine injury to the
emergency ââ?¬â?? ATC-OPD of PGIMER hospital, who need surgical treatment by anterior
approach will be assessed for eligibility and recruited in the study If they fulfill the following
inclusion criteria:
1. Patient of age >18 yrs. (of either sex).
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2. Patients (including pregnant females) with acute traumatic cervical spine injury and needs
surgical treatment by anterior approach.
3. Patient willing/giving consent and fit in pre-anaesthetic checkup.
4. Patient willing/giving written informed consent to take part in the study.
Patients will be excluded if any one of the following is present:
1. Prior cervical spine surgery
2. Myelopathy due to degenerative cause
3. Kyphotic alignment of cervical spine or straightened cervical curve
4. History of severe bleeding, coagulopathy, thrombocytopenia or other medically unfit
conditions.
5. Patients not willing to participate in study/ not giving consent.
6. Patients with any relative or absolute contraindications for surgery.
Patients will be assessed and recruited in the orthopaedics ATC- OPD in PGIMER. General
health checkup and a neurological examination will be performed for each subject. This
examination will include a general physical examination, lab tests (Hb, TLC, platelet count,
PT, PTI, INR, aPTT, serum electrolytes, renal function tests), resting ECG and chest X-ray.
Screening for markers for HIV, HBsAg and HCV will be done prior to surgery. For HIV
screening HIV consent form will be signed from the participant and report will be kept
confidential. No patient will be excluded on the basis of the results of these triple test
markers. A detailed history will be taken to see for any incipient disease.
Collection of biological samples-From all cases and controls participating in the study, a
3ml blood sample in EDTA vial will be collected and stored at -80�°C for genetic study. If
possible intervertebral disc sample will be taken from cases and control after proper informed
written consent of patient. This disc will be used to see the genetic expression. The frozen
human blood/ intervertebral disc sample quality and quantity of DNA will be checked by
agarose gel electrophoresis and spectrophotometry. The SNPs will be analyzed based on
previous genetic studies.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method