Safety Study of Femoral Neck Fracture System

Smith & Nephew, Inc.15 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Femoral Neck Fractures

Interventions

CONQUEST FN Femoral Neck Fracture SystemDEVICE

Fracture fixation device consisting of a single plate and three screws

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (4)

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

Outcomes

Primary Outcomes

Reoperation Rate at One Year Post-operation

Reoperation for any reason from time of implantation to one-year post operation

Time frame: 1 year

Secondary Outcomes

Number of Participants With Intraoperative Complications

Documentation of any complications related to the implantation of the device

Time frame: 7 days

Classification of Quality of Fracture Reduction

Appropriate reduction was defined as the principal compressive trabeculae measuring \>160° in the AP view and \<5° of posterior angulation in the lateral view. Fractures were then classified as: * Grade I * Grade II * Grade III If reduction was acceptable in both views, it was classified as Grade I. Grade II was indicative of one plane of malreduction, and Grade III was indicative of malreduction in both radiographic views.

Time frame: Operative, 6 weeks, 3 months, 6 months, and 1 year

Visual Analogue Scale (VAS) for Pain

The Visual Analogue Scale was simply a line of fixed length, on which the subject marked their experience of pain with a single stroke of a pen. At each specified visit, the participant was asked to indicate their average level of pain from the operated hip over the prior 24 hours using a visual analog scale (VAS). The participant recorded their level of pain on a 100 millimeter visual analog scale with scores ranging from 0 to 100. The scale marked 'no pain' (score of 0) on the left side of the scale and 'severe pain' (score of 100) at the right end of the scale. The participant was instructed to place a vertical mark on the scale, using an ink pen. The Investigator, or designee, measured the distance (in millimeters) from the left end of the VAS scale to the vertical line drawn by the participant. This value was entered in the participant's Case Report Form (CRF) as a measure of the pain associated with the operated hip.

Time frame: Pre-Operative, 6 Weeks, 3 Months, 6 Months, and 1 year

Data from ClinicalTrials.gov

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