Performance and safety evaluation of femoral nail for femur related fracture fixation.

Phase 4

Completed

• Conditions: Health Condition 1: Y793- Surgical instruments, materials and orthopedic devices (including sutures) associated with adverse incidents

• Registration Number: CTRI/2022/03/041158
• Lead Sponsor: Auxein Medical Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
?Fracture healing evaluated by X-ray images. <br/ ><br> ?Hip joint function evaluated by Harris hip scores. <br/ ><br> ?Pains on the affected region using VAS <br/ ><br>Timepoint: ?Fracture healing (Time frame : Baseline ,1,3,6,12 month) evaluated by X-ray images. <br/ ><br> ?Hip joint function evaluated by Harris hip scores.(Time frame : Baseline ,1,3,6,12 month) <br/ ><br> ?Pains on the affected region using VAS <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Complications & Adverse Events <br/ ><br>Timepoint: Time Frame: baseline, at 1, 3, 6, 12 months postoperatively.