CTRI/2021/02/031078进行中（未招募）未知
An exploratory study to evaluate the prevalence of Genetic polymorphism in patients with Cervical disc degeneration suffering from cervical Spondylotic myelopathy and correlation of gene expression: A genomic study in Cohort
Dr Vishal Kumar0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •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).
- •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
- •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.
排除标准
- •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).
- •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 -80Ã?°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.
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