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

  • STATUS
    Recruiting
  • End date
    Aug 24, 2023
  • participants needed
    50
  • sponsor
    Stryker Trauma GmbH
Updated on 24 March 2022
a 12
pseudarthrosis
knee arthroplasty

Summary

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.

Description

The objective of this clinical investigation is to demonstrate the safety and efficacy/performance of the Femoral Nail GT 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 GT 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 GT 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.

Details
Condition Femoral Fracture
Treatment Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System
Clinical Study IdentifierNCT04015128
SponsorStryker Trauma GmbH
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

Inclusion 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
Indications for Use approved Outside of Europe include
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 Criteria

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)
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