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
Trial Snapshot
- Phase
- Unknown
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- 3.To asses the safety and performance of Cannulated cancellous screws till 1 year follow-up.
Study Overview
Brief Summary
The Femur is the longest and largest bone in the body with abundant blood supply.The Femoral neck fractures occur in 2 to 3 % of skeletal injuries. Femoral Neck fractures(FNF) are widespread orthopedic injury which results in morbidity and mortality. Femoral neck fractures are very common in old age people but treatment of FNF in relatively young patients deserve attention.Femoral neck fractures usually occur by high- energy trauma, that is, fall from high places or high speed accident.The goal of the treatment in young patient is to retain the femoral neck fracture as much as possible to avoid necrosis of femoral head and achieve bone healing. There are about 4 types of distinct patterns as per the Garden fracture classification coded as Type I,II,III and IV.Interventions include surgical treatment of these fractures which lead to reduced mortality and complications. The implants used in surgical treatment for femoral neck fracture are Femoral Neck System, Dynamic Hip System and Cannulated Cancellous Screws.
Our Femoral Neck System, Dynamic Hip System and Cannulated Cancellous Screw based on the equivalence of design, production and final product inspection with the predicate device K100238 DEPUY ORTHOPAEDICS, INC DePuy Synthes and is being marketed nationally and globally from the year 2015. No serious adverse effects or complaints have been received till date for the systems.
As a manufacturer, Auxein has planned to conduct a Post-marketing clinical follow-up (PMCF) study following the CE marking of the device (Femoral neck System, Dynamic Hip System and Cannulated Cancellous Screw) marketed for its intended use and aims to verify the clinical performance and safety of the implant. We are conducting a prospective post-marketing surveillance study with 1 year post-operative follow-up to update the clinical performance and outcome of our device. Such studies are required by the regulatory authorities for all medical device implants that do not have medium to long-term clinical evidence available at the time of gaining approval to market.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 55.00 Year(s) (—)
- Sex
- All
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 Classiï¬cation) schedule for FNF surgery.
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 ï¬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.
Outcomes
Primary Outcomes
3.To asses the safety and performance of Cannulated cancellous screws till 1 year follow-up.
Time Frame: 0,1,3,6,12 Months
1.To asses the safety and performance of femoral neck system at 1 year follow-up
Time Frame: 0,1,3,6,12 Months
2.To asses the safety and performance of dynamic hip system till 1 year follow-up
Time Frame: 0,1,3,6,12 Months
Secondary Outcomes
- 1.Complications [Time Frame: baseline, at 1, 3, 6, 12 months postoperatively].(2.Adverse Events)