Health Condition 1: M628- Other specified disorders of muscle
Conditions
Interventions
None listed
Sponsors
Stavya spine hospital and research institute private limited
Eligibility
Inclusion criteria
Inclusion criteria: Age ââ?¬â?? 50 and above Male / female Physically fit and mentally Psycho-social, mentally and physically able to fully comply with this protocol including adhering to completing forms and other study procedures. 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: 1. Patients with heart disease, severe organ insufficiency 2. Patients with Diffused Idiopathic Skeletal Hyperostosis (DISH); 3. Active systemic or local infection; 4. Known or documented history of communicable disease, including AIDS or HIV; 5. Active hepatitis (receiving medical treatment within two years); 6. 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; 7. Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for > 1 month within last 12 months; 8. Known history of Pagetââ?¬•s disease, osteomalacia, or any other metabolic bone disease; 9. Previous known allergy to the materials contained in the device, such as titanium alloy (TAN); 10. Morbid obesity defined as a body mass index > 40 kg/m2 or weight more than 100 pounds over ideal body weight; 11. 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; 12. Current or recent history (within last 2 years) of substance abuse (e.g., recreational drugs, narcotics, or alcohol); 13. Pregnant or planning to become pregnant during study period; 14. Patients who are incarcerated. 15. Patients who have limited life expectancy due to significant medical comorbidities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Symptomatic relief in affected group 2.Measure their sagittal Angle 3.ScoreTimepoint: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Ergonomically oriented life style, change habits & improved health statusTimepoint: 2 year | — |
Countries
India
Contacts
Public ContactDr Bharat R Dave
Stavya Spine Hospital and Research Institute
Outcome results
None listed