Health Condition 1: M498- Spondylopathy in diseases classified elsewhere Health Condition 2: null- Variation in Hemodynamic parameters during lumbar spine surgery
Conditions
Interventions
Intervention1: Not Applicable: Not Applicable
Sponsors
Stavya Spine Hospital and Research Institute
Stavya Spine Hospital and Research Institute
Eligibility
Inclusion criteria
Inclusion criteria: Patients are included in the study if all of the following criteria are met: 1.All the patient who were admitted in sshri and posted for single level Transforaminal Lumber Interbody Fusion for stenosis or disc surgery by principal investigator. 2.Skeletally mature adult between the ages of 30-70 years at the time of surgery; 3.Psychosocially, mentally and physically able to fully comply with this protocol and other study procedures; 4.Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the study.
Exclusion criteria
Exclusion criteria: Patients are excluded from participating in this study if any of the following criteria are met: 1.More than one (1) vertebral level to be fused; 2.Has had previous lumbar spine surgery 3.Patients with anemia (hemoglobin 4.Patients with Diffused Idiopathic Skeletal Hyperostosis (DISH); 5.Active systemic or local infection; 6.Known or documented history of communicable disease, including AIDS or HIV; 7.Active hepatitis (receiving medical treatment within two years); 8.Active rheumatoid arthritis, non-controlled diabetes mellitus, or any other medical condition(s) that would represent a significant increase in surgical risk or interfere with normal healing; 9.Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for > 1 month within last 12 months; 10.Known history of Pagetâ??s disease, osteomalacia, or any other metabolic bone disease; 11.Previous known allergy to the materials contained in the device, such as titanium alloy (TAN); 12.Morbid obesity defined as a body mass index > 40 kg/m2 or weight more than 100 pounds over ideal body weight; 13.Active malignancy. A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and there has been no clinical signs or symptoms of the malignancy for more than 5 years; 14.Current or recent history (within last 2 years) of substance abuse (e.g., recreational drugs, narcotics, or alcohol); 15.Pregnant or planning to become pregnant during study period; 16.Patients who have limited life expectancy due to significant medical comorbidities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraoperative Assessment of Hemodynamic ParametersTimepoint: During the surgical period of 2 hrs or 2 hrs( what ever it may be) at each step as mention | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactDr Shaunak C Dudhia
Stavya Spine Hospital and Research Institute
Outcome results
None listed