Safety Study of Femoral Neck Fracture System

Study Overview
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Brief Summary
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The purpose of this study is to assess the reoperation rate of fractures that have occurred at the neck of the femur that are treated with the CONQUEST FN Femoral Neck Fracture System. The CONQUEST FN Femoral Neck Fracture System is approved for use by the United States Food and Drug Administration (FDA). It consists of a stainless steel plate and up to three (3) screws intended to treat both non-displaced and displaced fractures to the femoral neck.

Detailed Description
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The CONQUEST FN™ represents the next generation femoral neck fracture system designed to offer better intra-operative reduction control with the assurance of eliminating device failure modes. This system is dedicated to treating both non-displaced and displaced intracapsular fractures of the femoral neck. It is a dynamic locked implant system that provides multiple points of fixed angle support with continuous compression across the fracture site, ensuring bone-on-bone contact during the fracture union process. The continuous fracture site compression and post-operative reduction maintenance is accomplished with the incorporation of telescoping compression screw technology. The novel system empowers surgeons to address the current surgical challenges and often unfavorable patient outcomes and high re-operation rate associated with the current treatment options for intracapsular femoral neck fractures. This study will evaluate the re-operation rate for any reason of displaced and non-displaced femoral neck fractures treated with the CONQUEST FN Femoral Neck Fracture System at one year post-operation.

Official Title
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A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of CONQUEST FN for the Treatment of Intracapsular Femoral Neck Fractures

Conditions
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Femoral Neck Fractures

Intervention / Treatment
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* Device: CONQUEST FN Femoral Neck Fracture System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be 18 years of age or older Must provide written informed consent Willing to make all required study visits for one year post-operation Subject has experienced a displaced or non-displaced intracapsular femoral neck fracture and is scheduled for repair using the CONQUEST FN Femoral Neck Fracture System. Exclusion Criteria: Subject with known sensitivity or allergies to stainless steel Subject with fracture occurring more than 7 days prior to surgery Subject has more than one fracture on the hip requiring surgery Subject is considered obese by a Body Mass Index > 40 at the time of surgery Therapy with another investigational agent within thirty 30 days of screening Subject has emotional or neurological condition that precludes cooperation and compliance Subject has undergone previous surgery on hip. Subject has severe bow of the target hip or gross distortion of the femur. Current systemic therapy with cytotoxic drugs Subject has a physical condition that 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control femoral neck fracture system<br>This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture | Device: CONQUEST FN Femoral Neck Fracture System<br>* Fracture fixation device consisting of a single plate and three screws<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reoperation Rate at One Year Post-operation | Reoperation for any reason from time of implantation to one-year post operation | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Intraoperative Complications | Documentation of any complications related to the implantation of the device | 7 days | 
| Classification of Quality of Fracture Reduction | Appropriate reduction was defined as the principal compressive trabeculae measuring >160° in the AP view and <5° of posterior angulation in the lateral view. Fractures were then classified as: Grade I Grade II Grade III If reduction was acceptable in both views, it was classified as Grade I. Grade II was indicative of one plane of malreduction, and Grade III was indicative of malreduction in both radiographic views. | Operative, 6 weeks, 3 months, 6 months, and 1 year | 
| Visual Analogue Scale (VAS) for Pain | The Visual Analogue Scale was simply a line of fixed length, on which the subject marked their experience of pain with a single stroke of a pen. At each specified visit, the participant was asked to indicate their average level of pain from the operated hip over the prior 24 hours using a visual analog scale (VAS). The participant recorded their level of pain on a 100 millimeter visual analog scale with scores ranging from 0 to 100. The scale marked 'no pain' (score of 0) on the left side of the scale and 'severe pain' (score of 100) at the right end of the scale. The participant was instructed to place a vertical mark on the scale, using an ink pen. The Investigator, or designee, measured the distance (in millimeters) from the left end of the VAS scale to the vertical line drawn by the participant. This value was entered in the participant's Case Report Form (CRF) as a measure of the pain associated with the operated hip. | Pre-Operative, 6 Weeks, 3 Months, 6 Months, and 1 year | 
| Quality of Life - EQ-5D-5L | The EuroQol Five Dimensions (EQ-5D-5L) Questionnaire descriptive system consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), which are each assigned 5 levels: 1= no problems 2= slight problems 3= moderate problems 4= severe problems 5= extreme problems The respondent is asked to indicate his/her health using the most appropriate statement in each of the 5 dimensions. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for the five dimensions are combined in a 5-digit code describing the respondent's health state with scores ranging from -0.109 to 1 where higher scores indicate a better health state. | Pre-Operative, 6 Weeks, 3 Months, 6 Months, and 1 year | 
| 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. The site will follow the guidelines provided by the Centers for Disease Control and Prevention recording the results on the form provided by the Sponsor. | 6 Weeks, 3 Months, 6 Months, and 1 year | 
| Active Straight Leg Raise (ASLR) Assessment: Evaluation Score | The ASLR 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. Participants 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 participant 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). | 6 Weeks, 3 Months, 6 Months, and 1 year | 
| Number of Participants With Construct Failure | Construct failure past typical femoral neck fracture healing period (past 6 months) indicated by reported device deficiencies. | 6 months post-operative | 
| Length of Hospital Stay | Time spent in hospital measured by the number of days | During hospitalization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Femoral Neck Fracture, Hip, Broken hip, CONQUEST FN, Hip Fracture