FNS (FEMORAL NECK SYSTEM) Study

Wake Forest University (WFU)

Status: Active, not recruiting

Conditions: Femoral Neck Fractures

Study type: Observational

Funder types: Other

Identifiers

NCT04577261

IRB00066583

Details and patient eligibility

About

A post-market, prospective study to evaluate the reoperation rate of displaced and nondisplaced femoral neck fractures treated with the Femoral Neck System (FNS)™

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Femoral Neck System (FNS) Participants

Description:

Participants who will undergo surgery to treat a fractured femoral neck using the FNS (Femoral Neck System)