Thigh bone fracture and its union by using different implants study

Post Market Clinical follow-Up Study to evaluate the safety and performance of femoral neck system, dynamic hip system or cannulated cancellous screws in patient with femoral neck fracture - Nil

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061265

Enrollment

Registered

2024-01-09

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Femoral Neck system, Dynamic Hip Compression System, Cannulated Cancellous Screws: 12 Months intervention Control Intervention1: NA: NA

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
1.To asses the safety and performance of femoral neck system at 1 year follow-up 2.To asses the safety and performance of dynamic hip system till 1 year follow-up 3.To asses the safety and performance of Cannulated cancellous screws till 1 year follow-up.Timepoint: 0,1,3,6,12 Months	—

Secondary

Measure	Time frame
1.Complications [Time Frame: baseline, at 1, 3, 6, 12 months postoperatively]. 2.Adverse Events Pain on the affected region using VAS.Timepoint: 0,1,3,6,12 Months	—

Countries

India

Contacts

Public ContactMr Gaurav Luthra

clinical2@auxeinmedical.com7419660141

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026