Safety Study of Femoral Neck Fracture System



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:10/28/2018
Start Date:September 10, 2018
End Date:September 10, 2020
Contact:Natasha Schappell
Email:natasha.schappell@smith-nephew.com
Phone:817-302-3949

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A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of CONQUEST FN for the Treatment of Intracapsular Femoral Neck Fractures

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 three (3) screws
intended to treat both non-displaced and displaced fractures to the femoral neck.

The CONQUEST FN™ represents the next generation femoral neck fracture system designed to
offer better intra-operative reduction control with the assurance of eliminating device
failure modes. This system is dedicated to treating both non-displaced and displaced
intracapsular fractures of the femoral neck. It is a dynamic locked implant system that
provides multiple points of fixed angle support with continuous compression across the
fracture site, ensuring bone-on-bone contact during the fracture union process. The
continuous fracture site compression and post-operative reduction maintenance is accomplished
with the incorporation of telescoping compression screw technology. The novel system empowers
surgeons to address the current surgical challenges and often unfavorable patient outcomes
and high re-operation rate associated with the current treatment options for intracapsular
femoral neck fractures.

This study will evaluate the re-operation rate for any reason of displaced and non-displaced
femoral neck fractures treated with the CONQUEST FN Femoral Neck Fracture System at one year
post-operation.

Inclusion Criteria:

1. Must be 18 years of age or older

2. Must provide written informed consent

3. Willing to make all required study visits for one year post-operation

4. Subject has experienced a displaced or non-displaced intracapsular femoral neck
fracture and is scheduled for repair using the CONQUET FN Femoral Neck Fracture
System.

Exclusion Criteria:

1. Subject with known sensitivity or allergies to stainless steel

2. Subject with fracture occurring more than 7 days prior to surgery

3. Subject has more than one fracture on the hip requiring surgery

4. Subject is considered obese by a Body Mass Index > 40 at the time of surgery

5. Therapy with another investigational agent within thirty 30 days of screening
We found this trial at
4
sites
San Antonio, Texas 78229
Principal Investigator: Ravi Karia, MD
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from
San Antonio, TX
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Fort Worth, Texas 76107
Principal Investigator: Eric Barcak, DO
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mi
from
Fort Worth, TX
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Macon, Georgia 31201
Principal Investigator: Daniel Chan, MD
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mi
from
Macon, GA
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Winston-Salem, North Carolina 27157
Principal Investigator: Eben Carrol, MD
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mi
from
Winston-Salem, NC
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