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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Femoral Neck System (FNS) Participants | Participants who will undergo surgery to treat a fractured femoral neck using the FNS (Femoral Neck System) |
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| 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)™ | Year 1 post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Subject has experienced displaced or non-displaced intracapsular femoral neck fracture
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| Name | Affiliation | Role |
|---|---|---|
| Eben A Carroll, MD | Wake Forest Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26233991 | Background | Kenan S, Gold A, Salai M, Steinberg E, Ankory R, Chechik O. Long-Term Outcomes Following Reduction and Fixation of Displaced Subcapital Hip Fractures in the Young Elderly. Isr Med Assoc J. 2015 Jun;17(6):341-5. | |
| 28250858 | Background | Han S, Oh M, Yoon S, Kim J, Kim JW, Chang JS, Ryu JS. Risk Stratification for Avascular Necrosis of the Femoral Head After Internal Fixation of Femoral Neck Fractures by Post-Operative Bone SPECT/CT. Nucl Med Mol Imaging. 2017 Mar;51(1):49-57. doi: 10.1007/s13139-016-0443-8. Epub 2016 Aug 11. |
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| ID | Term |
|---|---|
| D005265 | Femoral Neck Fractures |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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| 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. | 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. | Baseline, Week 6, Months 3, 6, and 12 |
| Visual Analogue Scale (VAS) for Pain Score | 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 - It is generally accepted that a pain VAS score of 30, 70, and 100 indicates the upper boundaries of mild, moderate, and severe pain intensity | Baseline, Week 6, Months 3, 6, and 12 |
| 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, Week 6, Months 3, 6, and 12 |
| Active Straight Leg Raise (ASLR) Assessment Score | 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 | Baseline, Week 6, Months 3, 6, and 12 |
| Number of Participants with Intraoperative complications | Number of Participants with Intraoperative complications | Baseline, Week 6, Months 3, 6, and 12 |
| 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, Week 6, Months 3, 6, and 12 |
| Number of Construct failure past 6 months | Construct failure past typical femoral neck fracture healing period (past 6 months) | Months 6 and 12 |
| Time to return to full weight-bearing | Time to return to full weight-bearing | Week 6, Months 3, 6, and 12 |
| 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, Week 6, Months 3, 6, and 12 |
| Length of hospital stay | Length of hospital stay | Week 6, Months 3, 6, and 12 |
| Number of Hospital readmission for any reason | Number of Hospital readmission for any reason | Week 6, Months 3, 6, and 12 |
| 16445160 | Background | Farooq MA, Orkazai SH, Okusanya O, Devitt AT. Intracapsular fractures of the femoral neck in younger patients. Ir J Med Sci. 2005 Oct-Dec;174(4):42-5. doi: 10.1007/BF03168981. |
| 29106948 | Background | Campenfeldt P, Hedstrom M, Ekstrom W, Al-Ani AN. Good functional outcome but not regained health related quality of life in the majority of 20-69 years old patients with femoral neck fracture treated with internal fixation: A prospective 2-year follow-up study of 182 patients. Injury. 2017 Dec;48(12):2744-2753. doi: 10.1016/j.injury.2017.10.028. Epub 2017 Oct 18. |
| D025981 |
| Hip Injuries |
| D007869 | Leg Injuries |