Health Condition 1: M471- Other spondylosis with myelopathy Health Condition 2: M483- Traumatic spondylopathy
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Dr Vishal Kumar
Eligibility
Inclusion criteria
Inclusion criteria: 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). 20 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.
Exclusion criteria
Exclusion criteria: 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). 21 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disc degeneration is strongly associated with genetic polymorphism in genes of Collagen 11A2, Calmodulin 1, IL6 and MMP9 genes and alternation in genetic expression of activity of MAP2K6 and RHOBTB2 genes.Timepoint: 18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Chronic low back ache and neck pain in young adults are due to disc degeneration and are governed by genetic polymorphism of above interest genes.Timepoint: may manifest as early as 20 years of age or even in children and is usually seen in elder individuals. Our time point is to see the duration of chronic pain in each subject which can vary from weeks to years. | — |
Countries
India
Contacts
Public ContactDr Vishal Kumar
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH Chandigarh
Outcome results
None listed