Shoulder bone fracture union study
Phase 4
- Conditions
- Health Condition 1: M959- Acquired deformity of musculoskeletal system, unspecified
- Registration Number
- CTRI/2023/11/060230
- Lead Sponsor
- Auxein Medical Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1 Subjects are willing and able to give informed consent for participation as well as willing for study follow ups
2 Male and female subjects aged between 18 years to 75 years
3 Subjects with confirmed diagnosis as per the indications as mentioned in investigators brochure
Exclusion Criteria
1 Infection local or Systemic Acute or Chronic Inflammation to the operative site
2 Female subject who is pregnant or planning pregnancy during the course of the study
3 Subject having Soft tissue or material sensitivity
4 Subjects who are unwilling or incapable of following post operative care instructions
5 Subjects having diagnosed Sepsis
6 Subjects who are incarcerated or have pending incarceration
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Completion of clinical investigationTimepoint: Twelve months
- Secondary Outcome Measures
Name Time Method Analyzing Visual analogue score for pain assessment <br/ ><br> <br/ ><br>Any adverse event or serious adverse event during follow up especially the one mentioned in the Investigators BrochureTimepoint: Twelve Months