Thigh bone fracture and its union by using different implants study
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2024/01/061265
- Lead Sponsor
- Auxein Medical Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Subject is willing and able to give informed consent for participation in the study.
2.Male and female above 18 years to 55 year skeletally mature patients.
3.Subject with Femoral Neck Fracture of III and IV class (Garden Classi ?cation) schedule for FNF surgery.
1.Pathological fractures,open fractures or other fractures including poly- trauma, stress fractures of the femoral neck
2.Local infection in the hip joint before the ?xation surgery.
3.Patient with previously diagnosed osteoporosis.
Fracture-dislocation of the femoral neck and hip joint.
4.Likely problems, in the judgement of the attending surgeon, with maintaining follow up.
5.Patients with severe mental disorders and 6.psychotropic drug addictions.
7.Pregnancy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To asses the safety and performance of femoral neck system at 1 year follow-up <br/ ><br>2.To asses the safety and performance of dynamic hip system till 1 year follow-up <br/ ><br>3.To asses the safety and performance of Cannulated cancellous screws till 1 year follow-up.Timepoint: 0,1,3,6,12 Months
- Secondary Outcome Measures
Name Time Method 1.Complications [Time Frame: baseline, at 1, 3, 6, 12 months postoperatively]. <br/ ><br>2.Adverse Events <br/ ><br>Pain on the affected region using VAS.Timepoint: 0,1,3,6,12 Months