Clinical trial NCT04577261: FNS (FEMORAL NECK SYSTEM) Study
Official title: A Prospective Study To Evaluate The FEMORAL NECK SYSTEM (FNS) In The Treatment Of INTRA-CAPSULAR FEMORAL Neck Fractures
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Femoral Neck Fractures
Keywords: neck fractures
implant failure
osteotomy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-10-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject has experienced displaced or non-displaced intracapsular femoral neck fracture

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

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.

Primary outcomes:
measure: Re-operation rate
timeFrame: Year 1 post-operation
Secondary outcomes:
measure: Timed Up and Go (TUG) time
timeFrame: Week 6, Months 3, 6, and 12
measure: European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) Score
timeFrame: Baseline, Week 6, Months 3, 6, and 12
measure: European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) - VAS (Visual Analogue Scale) Score
timeFrame: Baseline, Week 6, Months 3, 6, and 12
measure: Visual Analogue Scale (VAS) for Pain Score
timeFrame: Baseline, Week 6, Months 3, 6, and 12
measure: Number of Participants with Quality of Fracture Reduction
timeFrame: Baseline, Week 6, Months 3, 6, and 12
measure: Active Straight Leg Raise (ASLR) Assessment Score
timeFrame: Baseline, Week 6, Months 3, 6, and 12
measure: Number of Participants with Intraoperative complications
timeFrame: Baseline, Week 6, Months 3, 6, and 12
measure: Radiographic outcomes including quality of fracture reduction
timeFrame: Baseline, Week 6, Months 3, 6, and 12
measure: Number of Construct failure past 6 months
timeFrame: Months 6 and 12
measure: Time to return to full weight-bearing
timeFrame: Week 6, Months 3, 6, and 12
measure: Ambulatory status from pre-injury to study completion
timeFrame: Baseline, Week 6, Months 3, 6, and 12
measure: Length of hospital stay
timeFrame: Week 6, Months 3, 6, and 12
measure: Number of Hospital readmission for any reason
timeFrame: Week 6, Months 3, 6, and 12
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest Health Sciences
name: Eben A Carroll, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.