FNS (FEMORAL NECK SYSTEM) Study

N/AActive Not RecruitingNCT04577261

Wake Forest University Health Sciences50 enrolled

Overview

A post-market, prospective study to evaluate the reoperation rate of displaced and nondisplaced femoral neck fractures treated with the Femoral Neck System (FNS)™

To evaluate the re-operation rate for any reason of displaced and non-displaced femoral neck fractures treated with the Femoral Neck System (FNS)™ at one year post-operation. The Femoral Neck System (FNS)™ represents a new generation of implants designed to improve outcomes in the treatment of femoral neck fractures. These implants offer a fixed angle construct and all of its mechanical advantages with regards to neutralizing shear and providing stability while not exerting a rotational malreduction force on the fracture. The FNS system has been shown to compare favorably to traditional fixed angle constructs in a cadaveric model

Study Type

OBSERVATIONAL

Enrollment

Conditions

Femoral Neck Fractures

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The subject must provide written informed consent * The subject must be eighteen (18) years of age or older. * The subject must be willing and able to make all required study visits including one (1) year post-operative follow-up. * The subject must be able to follow instructions. * Subject has experienced displaced or non-displaced intracapsular femoral neck fracture Exclusion Criteria: * Subject with fracture occurring more than 7 days prior to the date of surgery * Subject has more than one fracture on target extremity. * Subject is obese as defined by a Body Mass Index (BMI) \> 45 at the time of surgery. * Subject, in the opinion of the Investigator, has an emotional or neurological condition that preludes cooperation and compliance with the rehabilitation regimen. * Therapy with another investigational agent within thirty (30) days of Screening or planned therapy with another investigational agent during the course of the study. * Subject has a physical condition that, in the opinion of the Investigator, would preclude adequate implant support or impede healing (e.g. blood supply impairment insufficient bone quality or quantity, or an active, local or systemic infection). If this is identified at the time of surgery, the subject will be screen failed. * Subject has undergone previous surgery on the target hip. * Current systemic therapy with cytotoxic drugs. * Subjects with a history of poor compliance with medical treatment. * Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

Locations (1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Re-operation rate

Re-operation rate for any reason of displaced and non-displaced femoral neck fractures treated with the Femoral Neck System (FNS)™

Time frame: Year 1 post-operation

Secondary Outcomes

Timed Up and Go (TUG) time

The Timed Up and Go Test assesses mobility, balance, walking ability, and fall risk in adults by measuring time, in seconds, that it takes the individual to stand from a chair, walk a distance of 10 feet, walk back to the chair, and sit down. The subject will perform the test in their everyday footwear with their walking aid (cane, walker), if applicable. Normal healthy elderly usually complete the task in ten seconds or less. Very frail or weak elderly with poor mobility may take 2 minutes or more. 8

Time frame: Week 6, Months 3, 6, and 12

European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) Score

The EuroQol EQ-5D-5L is a standardized instrument for use as a measurement of health outcome. It consists of a descriptive system with 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), which are each assigned five levels (no problems, slight problems, moderate problems, severe problems and extreme problems) The first part (descriptive system with 5 dimensions) is scored using the Health state index scores. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.

Time frame: Baseline, Week 6, Months 3, 6, and 12

European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) - VAS (Visual Analogue Scale) Score

The EuroQol EQ-5D-5L is a standardized instrument for use as a measurement of health outcome. It consists of a descriptive system with 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), which are each assigned five levels (no problems, slight problems, moderate problems, severe problems and extreme problems), as well as, a Visual Analogue Scale where subjects indicate a numerical value from 0-100 where 0 is the worst imaginable health state and 100 is the best imaginable health state.

Data from ClinicalTrials.gov

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