Safety Study of Femoral Neck Fracture System

Stopped early · Not applicable

Conditions studied: Femoral Neck Fractures

In brief

The purpose of this study is to assess the reoperation rate of fractures that have occurred at the neck of the femur that are treated with the CONQUEST FN Femoral Neck Fracture System. The CONQUEST FN Femoral Neck Fracture System is approved for use by the United States Food and Drug Administration (FDA). It consists of a stainless steel plate and up to three (3) screws intended to treat both non-displaced and displaced fractures to the femoral neck.

Key facts

Study ID

NCT03721835

Run by

Smith & Nephew, Inc.

People needed

15

Starts

2018-09-10

Expected to finish

2020-02-11

Last updated by the study team

2023-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must be 18 years of age or older
• Must provide written informed consent
• Willing to make all required study visits for one year post-operation
• Subject has experienced a displaced or non-displaced intracapsular femoral neck fracture and is scheduled for repair using the CONQUEST FN Femoral Neck Fracture System.

You may not qualify if…

• Subject with known sensitivity or allergies to stainless steel
• Subject with fracture occurring more than 7 days prior to surgery
• Subject has more than one fracture on the hip requiring surgery
• Subject is considered obese by a Body Mass Index > 40 at the time of surgery
• Therapy with another investigational agent within thirty 30 days of screening
• Subject has emotional or neurological condition that precludes cooperation and compliance
• Subject has undergone previous surgery on hip.
• Subject has severe bow of the target hip or gross distortion of the femur.
• Current systemic therapy with cytotoxic drugs
• Subject has a physical condition that 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).

Where it is running

• Orthopaedic Trauma Institute Navicent Health Medical Center — Macon, Georgia, United States
• Wake Forest School of Medicine — Winston-Salem, North Carolina, United States
• John Peter Smith Hospital — Fort Worth, Texas, United States
• UT Health Science Center San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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