Health Condition 1: Y793- Surgical instruments, materials and orthopedic devices (including sutures) associated with adverse incidents
Conditions
Interventions
Intervention1: Proximal femoral Nail Antirotation (PFNA): Nail implant intended for femoral fracture fixation
Control Intervention1: NOT APPLICABLE: NOT APPLICABLE
Sponsors
Auxein Medical Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1] Subject is willing and able to give informed consent for participation in the study. 2] Male or Female, aged 18 years or above, skeletally mature patient. 3] Subject suffering from any of the following conditions: Comminuted fracture / Segmental fracture / Proximal and distal fracture / Non-unions / Sub-trochanteric fracture / Inter-trochanteric fracture. 4] Subject is willing and able to complete required study visits or assessments. 5]Participant has confirmed diagnosis as per the indications
Exclusion criteria
Exclusion criteria: 1. Isolated or combined medial femoral neck fractures 2. Low sub-trochanteric fractures 3. Femoral shaft fractures 4. Isolated or combined medial femoral neck fractures 5. Medial neck fracture 6. Signs of local inflammation 7. Infection local to the operative site 8. Fever or leukocytosis. 9. Neuromuscular disorders which can create unacceptable risk of fixation failure or complications in postoperative care. 10. Any other condition which would preclude the potential benefit of implant insertion surgery and disturb the normal process of bone remodeling, e.g. the presence of tumours or congenital abnormalities, fracture local to the operating site, elevation of sedimentation rate unexplained by other diseases, elevation of white blood cells (WBC) count, or a marked left shift in the WBC differential count. 11. Suspected or documented allergy or intolerance to implant materials. Surgeon shall find out if the patient develops allergic reaction to the material of the implant (content of the implant material is presented in IMPLANT MATERIAL). 12. Any case not needing a surgical intervention. 13. Any case not described in the indications. 14. Any patient unwilling to cooperate with postoperative instructions; mental illness, a condition of senility or substance abuse may cause the patient to ignore certain necessary limitations and precautions in the implant usage. 15. Any case where the implant components selected for use would be too large or too small to achieve a successful result. 16. Any case that requires the simultaneous use of elements from different systems that are made of different metals. 17. Any case in which implant utilization would disturb physiological processes. 18. Blood supply limitation in the operative site. 19. Morbid obesity (defined according to the WHO standards). 20. Any case in which there is inadequate tissue coverage of the operative site. 21. Shaft fractures with a fissure less than 5 cm from the nearest interlocking hole of the nail.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ?Fracture healing evaluated by X-ray images. ?Hip joint function evaluated by Harris hip scores. ?Pains on the affected region using VAS Timepoint: ?Fracture healing (Time frame : Baseline ,1,3,6,12 month) evaluated by X-ray images. ?Hip joint function evaluated by Harris hip scores.(Time frame : Baseline ,1,3,6,12 month) ?Pains on the affected region using VAS | — |
Secondary
| Measure | Time frame |
|---|---|
| Complications & Adverse Events Timepoint: Time Frame: baseline, at 1, 3, 6, 12 months postoperatively. | — |
Countries
India
Contacts
Public ContactMr Gaurav Luthra
Auxein Medical Pvt. Ltd.
Outcome results
None listed