To study the posture change in Indian population after 50 years of age

Not Applicable

• Conditions: Health Condition 1: M628- Other specified disorders of muscle

• Registration Number: CTRI/2019/08/020540
• Lead Sponsor: Stavya spine hospital and research institute private limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Age 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

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 Pagetâ??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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1 Symptomatic relief in affected group <br/ ><br>2.Measure their sagittal Angle <br/ ><br>3.ScoreTimepoint: 2 years

Secondary Outcome Measures

Name	Time	Method
Ergonomically oriented life style, change habits & improved health statusTimepoint: 2 year