FNS (FEMORAL NECK SYSTEM) Study
Completed
Conditions studied: Femoral Neck Fractures
In brief
A post-market, prospective study to evaluate the reoperation rate of displaced and nondisplaced femoral neck fractures treated with the Femoral Neck System (FNS)™
Key facts
- Study ID
- NCT04577261
- Run by
- Wake Forest University Health Sciences
- People needed
- 43
- Starts
- 2020-10-07
- Expected to finish
- 2026-04-02
- Last updated by the study team
- 2026-05-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Wake Forest Health Sciences — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
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