Status:
RECRUITING
A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail PF
Lead Sponsor:
Stryker Trauma and Extremities
Conditions:
Femoral Fracture
Eligibility:
All Genders
18-80 years
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 2...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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).
Key Trial Info
Start Date :
September 12 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04015154
Start Date
September 12 2019
End Date
June 1 2025
Last Update
June 6 2024
Active Locations (5)
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1
St. Cloud Orthopedic Associates, Ltd
Sartell, Minnesota, United States, 56377
2
Reno Orthopedic Clinic
Reno, Nevada, United States, 89503
3
Ariana Meltzer-Bruhn
New York, New York, United States, 10016
4
UC Health
Cincinnati, Ohio, United States, 45229