A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail GT

Description

This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of 50 subjects will be enrolled. Neither subjects nor investigators are blinded to treatment and the clinical investigation includes a historical control which will be compared to the Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System. Total duration of enrollment, 12 month follow-up and analysis is expected to take 25 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 GT of the T2 Alpha Femur Antegrade GT/PF Nailing System compared to the T2 Femur benchmark literature.

Conditions

Femoral Fracture

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Study Overview

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Study Details

Study overview

This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of 50 subjects will be enrolled. Neither subjects nor investigators are blinded to treatment and the clinical investigation includes a historical control which will be compared to the Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System. Total duration of enrollment, 12 month follow-up and analysis is expected to take 25 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 GT of the T2 Alpha Femur Antegrade GT/PF Nailing System compared to the T2 Femur benchmark literature.

A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail Greater Trochanter (GT) of the T2 Alpha Femur Antegrade GT/PF Nailing System

A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail GT

Condition
Femoral Fracture
Intervention / Treatment

-

Contacts and Locations

Sartell

St. Cloud Orthopedic Associates, Ltd, Sartell, Minnesota, United States, 56377

Reno

Reno Orthopedic Clinic, Reno, Nevada, United States, 89503

New York

New York University, New York, New York, United States, 10016

Cincinnati

UC Health, Cincinnati, Ohio, United States, 45229

Memphis

Regional One Health, Memphis, Tennessee, United States, 38103

Falls Church

Inova Fairfax Medical Campus, Falls Church, Virginia, United States, 22042

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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 GT of the T2 Alpha Femur Antegrade GT/PF Nailing System in accordance with the following legally cleared/ approved 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).

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stryker Trauma and Extremities,

Rebecca Gibson, STUDY_DIRECTOR, rebecca.gibson@stryker.com

Study Record Dates

2024-12