FNS (FEMORAL NECK SYSTEM) Study (NCT04577261) | Clinical Trial Compass
CompletedNot Applicable
FNS (FEMORAL NECK SYSTEM) Study
United States43 participantsStarted 2020-10-07
Plain-language 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)â„¢
Who can participate
Age range18 Years
SexALL
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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 me…