CTRI/2023/05/052536
Completed
Phase 4
A non- randomized, prospective Post Market Clinical Follow-up study to evaluate the Safety and Performance of elastic nailing
Auxein Medical Pvt Ltd0 sites30 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- 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
- Sponsor
- Auxein Medical Pvt Ltd
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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