Summary

for people ages 18 years and up (full criteria)
at Orange, California and other locations
study started
estimated completion
John Scolaro, MD

Description

Summary

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.

Official Title

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

Details

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.

Keywords

Femoral Neck Fractures Femoral Neck Fracture Hip Broken hip CONQUEST FN Hip Fracture Fractures, Bone CONQUEST FN Femoral Neck Fracture System

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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
  6. Subject has emotional or neurological condition that precludes cooperation and compliance
  7. Subject has undergone previous surgery on hip.
  8. Subject has severe bow of the target hip or gross distortion of the femur.
  9. Current systemic therapy with cytotoxic drugs
  10. . 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).

Locations

  • University of California, Irvine not yet accepting patients
    Orange California 92868 United States
  • UT Health Science Center San Antonio accepting new patients
    San Antonio Texas 78829 United States

Lead Scientist

  • John Scolaro, MD
    Associate Clinical Professor, Orthopaedic Surgery. Authored (or co-authored) 50 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Smith & Nephew, Inc.
ID
NCT03721835
Study Type
Interventional
Last Updated