Safety Study of Femoral Neck Fracture System

NCT ID: NCT03721835

Last Updated: 2023-09-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-10
• Study Completion Date: 2020-02-11

Brief 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.

Detailed Description

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.

Conditions

Femoral Neck Fractures

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control femoral neck fracture system

This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture

Group Type: OTHER

CONQUEST FN Femoral Neck Fracture System

Intervention Type: DEVICE

Fracture fixation device consisting of a single plate and three screws

Interventions

CONQUEST FN Femoral Neck Fracture System

Fracture fixation device consisting of a single plate and three screws

Intervention Type: DEVICE

Eligibility Criteria

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 CONQUEST 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

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karlie Morgan

Role: STUDY_CHAIR

Smith & Nephew, Inc.

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

18-3047-02

Identifier Type: -

Identifier Source: org_study_id