Performance and safety evaluation of elastic nailing system
Phase 4
Completed
- Conditions
- Health Condition 1: S723- Fracture of shaft of femurHealth Condition 2: S824- Fracture of shaft of fibulaHealth Condition 3: S423- Fracture of shaft of humerusHealth Condition 4: S523- Fracture of shaft of radiusHealth Condition 5: S822- Fracture of shaft of tibiaHealth Condition 6: S522- Fracture of shaft of ulna
- Registration Number
- CTRI/2023/05/052536
- Lead Sponsor
- Auxein Medical Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fracture fusionTimepoint: at 12 months postoperatively
- Secondary Outcome Measures
Name Time Method Rate of implant related, surgery related, postoperative and general complicationsTimepoint: 1, 3, 6 month