Health Condition 1: S723- Fracture of shaft of femur Health Condition 2: S824- Fracture of shaft of fibula Health Condition 3: S423- Fracture of shaft of humerus Health Condition 4: S523- Fracture of shaft of radius Health Condition 5: S822- Fracture of shaft of tibia Health Condition 6: S522- Fracture of shaft of ulna
Conditions
Interventions
Intervention1: Elastic Nailing system: The AUXEIN MEDICALs Elastic Intramedullary Nail System is indicated
for management of diaphyseal and certain metaphyseal/epiphyseal fracture
of long bones in chi
Sponsors
Auxein Medical Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subject legal Guardian/ Parent willing and able to give informed consent for participation in the study. Girl and Boy between 6 to 15 years. Subject diagnosed with diaphyseal fractures, metaphyseal and epiphyseal fractures of long bones.
Exclusion criteria
Exclusion criteria: Local or Systemic acute or chronic inflammation. Active infection or inflammation. Suspected or documented metal allergy or intolerance. Symptomatic Arthiritis Patient with Mental Disorders as well as comprehensive legal support. Lack of willingness to make a commitment to return for required follow up visits. Drug and/or alcohol abuse. Morbid obesity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fracture fusionTimepoint: at 12 months postoperatively | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of implant related, surgery related, postoperative and general complicationsTimepoint: 1, 3, 6 month | — |
Countries
India
Contacts
Public ContactMr Gaurav Luthra
Auxein Medical Pvt. Ltd.
Outcome results
None listed