Health Condition 1: M959- Acquired deformity of musculoskeletal system, unspecified
Conditions
Interventions
Intervention1: Clavicle plate system: Duration of intervention - 1 year
Control Intervention1: NA: NA
Sponsors
Auxein Medical Pvt Ltd
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Completion of clinical investigationTimepoint: Twelve months | — |
Secondary
| Measure | Time frame |
|---|---|
| Analyzing Visual analogue score for pain assessment Any adverse event or serious adverse event during follow up especially the one mentioned in the Investigators BrochureTimepoint: Twelve Months | — |
Countries
India
Contacts
Public ContactMr Gaurav Luthra
Auxein Medical Pvt Ltd
Outcome results
None listed