A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail PF
- Conditions
- Femoral Fracture
- Interventions
- Device: Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System
- Registration Number
- NCT04015154
- Lead Sponsor
- Stryker Trauma and Extremities
- Brief Summary
This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of 50 subjects will be enrolled at up to 5 sites. Enrollment is estimated to commence in Q4 of 2018. Neither subjects nor investigators are blinded to treatment and the clinical investigation includes a historical control which will be compared to the Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System.
Total duration of enrollment, 12 month follow-up and analysis is expected to take 29 months. The clinical investigation has been designed to follow the surgeon's standard of care for femur fractured subjects, in addition to a 12 month follow-up visit.
The primary endpoint of this clinical investigation is to confirm efficacy/performance at 12 months, as measured by the Lower Extremity Measure (LEM). Confirmation of efficacy/performance at 12 months will be based on an equal or greater (non-inferior) LEM score result of the Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System compared to the T2 Femur benchmark literature.
- Detailed Description
The objective of this clinical investigation is to demonstrate the safety and efficacy/performance of the Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System. Efficacy/performance of the procedure will be measured by an equal or greater (non-inferior) Lower Extremity Measure (LEM) score result of the Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System compared to the T2 Femur benchmark literature at 12 months.
In addition, demonstration of bone consolidation in correct alignment will be measured by Investigator assessment by 12 months. Safety of the Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System will be demonstrated through reporting of device related intra-operative and post-operative Adverse Events/incidents by 12 months.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Subject is a male or non-pregnant female age 18 years or older at the time of surgery;
- Subject is willing and able to give written informed consent and comply with the requirements of this Clinical Investigation Plan;
- Subject is intended to be treated with the Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System in accordance with the following legally cleared/ approved Indications for Use:
Indications for Use:
- Fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, comminuted proximal femoral shaft fractures
- Femoral fixation required as a result of pathological disease
- Temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur
- Open and closed femoral fractures
- Pseudoarthrosis and correction osteotomy
- Pathologic fractures, impending pathologic fractures and tumor resections
- Ipsilateral femur fractures
- Fractures proximal to a total knee arthroplasty
- Nonunions and malunions
- Fractures involving osteopenic and osteoporotic bone
- Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device clinical investigation that, in the opinion of the Investigator, may confound results;
- Per the Investigator, the subject is in poor general health or undergoing any concurrent disease that would place the subject in excessive risk to surgery (i.e. significant circulatory problems, cardiac disease).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description T2 Alpha Femoral Nail PF Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System Subjects in the clinical investigation will undergo placement of the Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System which allows for insertion through the piriformis fossa, according to the Instructions for Use and Operative Technique Manual
- Primary Outcome Measures
Name Time Method Lower Extremity Measure (LEM) 12 months The primary endpoint of this clinical investigation is to confirm efficacy/performance at 12 months, as measured by the Lower Extremity Measure (LEM). Confirmation of efficacy/performance at 12 months will be based on an equal or greater (non-inferior) LEM score result of the Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System compared to the T2 Femur benchmark literature
- Secondary Outcome Measures
Name Time Method Safety will be measured by capturing the incidence rate of device-related adverse events 12 months Incidence of device-related adverse events will be monitored by 12 months through data collection and analyses.
Efficacy/Performance will be measured by demonstration of bone consolidation 12 months Bone consolidation will be assessed by 12 months as measured by Investigator assessment.
Trial Locations
- Locations (5)
Ariana Meltzer-Bruhn
🇺🇸New York, New York, United States
UC Health
🇺🇸Cincinnati, Ohio, United States
Inova Fairfax Medical Campus
🇺🇸Falls Church, Virginia, United States
Reno Orthopedic Clinic
🇺🇸Reno, Nevada, United States
St. Cloud Orthopedic Associates, Ltd
🇺🇸Sartell, Minnesota, United States