FNS (FEMORAL NECK SYSTEM) Study

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

Detailed Description
-----------------
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

Official Title
-----------------
A Prospective Study To Evaluate The FEMORAL NECK SYSTEM (FNS) In The Treatment Of INTRA-CAPSULAR FEMORAL Neck Fractures

Conditions
-----------------
Femoral Neck Fractures

Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FNS Participants<br>Participants who will undergo surgery to treat a fractured femoral neck using the FNS (Femoral Neck System) | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| re-operation rate | re-operation rate for any reason of displaced and non-displaced femoral neck fractures treated with the Femoral Neck System (FNS)™ | one year post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up and Go (TUG) | 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. | 6-weeks, 3-month, 6-month and 12-month follow-up visits | 
| EuroQol EQ-5D-5L | 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. | baseline, 6-weeks, 3-month, 6-month and 12-month follow-up visits | 
| EuroQol EQ-5D-5L - VAS (Visual Analogue Scale) | 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. | baseline, 6-weeks, 3-month, 6-month and 12-month follow-up visits | 
| Visual Analogue Scale (VAS) for Pain | The Visual Analogue Scale is simply a line of fixed length, on which the subject marks their experience of pain with a single stroke of a pen - The subject will record their level of pain on a 100 mm visual analog scale - the scale will be marked 'no pain' on the left side of the scale and 'severe pain' at the right end of the scale | baseline, 6-weeks, 3-month, 6-month and 12-month follow-up visits | 
| Number of Participants with Quality of Fracture Reduction | Appropriate reduction will be defined as the principal compressive trabeculae measuring >160° in the AP view and <5° of posterior angulation in the lateral view. If reduction is acceptable in both views, it will be classified as grade I. Grade II will be indicative of one plane of malreduction, and grade III will be indicative of malreduction in both radiographic views. Pre-operative radiographs will be reviewed and classified as displaced (e.g. Garden III & IV) or non-displaced (e.g. Garden I & II) femoral neck fractures by the Investigator at each site Pauwel Classification (Type I - 30 degrees, Type II - 50 degrees, Type III - 70 degrees) | baseline, 6-weeks, 3-month, 6-month and 12-month follow-up visits | 
| Active Straight Leg Raise (ASLR) Assessment | The ALSR assessment provides information about the ability of load transfer and motor control strategies in the lumbo/pelvic/hip complex. ASLR will be performed with the subject in a relaxed supine position with legs straight and feet apart. Subjects will be instructed to raise their operated leg 20cm above the examination table without bending the knee and without pelvic movement relative to the trunk. A score will be provided by the subject for the operated limb on a six-point Likert scale (0 = not difficult at all, 1 = minimally difficult; 2 = somewhat able to do, 3 = fairly difficult, 4 = very difficult, 5 = unable to do) -Lower score denotes better outcome | 6-weeks, 3-month, 6-month and 12-month follow-up visits | 
| Number of Participants with Intraoperative complications |  | baseline, 6-weeks, 3-month, 6-month and 12-month follow-up visits | 
| Radiographic outcomes including quality of fracture reduction | Perform radiology imaging collecting both anteroposterior (AP) and lateral images of the target hip to ensure the FNS is properly implanted - (healed, non-union, aligned, mal-union, osteonecrosis of femoral head, no osteonecrosis of femoral head, none) | baseline, 6-weeks, 3-month, 6-month and 12-month follow-up visits | 
| Number of Construct failure past 6 months | Construct failure past typical femoral neck fracture healing period (past 6 months) | 6-month and 12-month follow-up visits | 
| Time to return to full weight-bearing |  | 6-weeks, 3-month, 6-month and 12-month follow-up visits | 
| Ambulatory status from pre-injury to study completion | Subjects will be assessed as Unaided, Using a cane, Using a walker or Bed to Chair | baseline, 6-weeks, 3-month, 6-month and 12-month follow-up visits | 
| Length of hospital stay |  | 6-weeks, 3-month, 6-month and 12-month follow-up visits | 
| Number of Hospital readmission for any reason |  | 6-weeks, 3-month, 6-month and 12-month follow-up visits | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neck fractures, implant failure, osteotomy