Retrograde Femoral Nail-Advanced Outcomes for Fixation of Distal Femur and Femoral Shaft Fractures

University of California, San Diego40 enrolled

Overview

This project consists of a prospective and retrospective case series design. Study candidates will include all patients 18 years or older, who were evaluated at UCSD and found to have a distal femur or femoral shaft fracture requiring surgical fixation. Patients who consent to study participation will recieve the RFN-advanced Retrograde Femoral Nailing System implant for fracture fixation. Data on functional status, healing rates, complication rates, and pain levels will be collected for each participant. After 3 years of data collection, investigators will analyze this data to provide further insight on the utility of this new design of retrograde femoral nails. Given the relatively high rate of complications, such as malalignment, with current femoral nail designs, it is imperative to evaluate novel systems to appropriately manage distal femur or femoral shaft fractures.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Femoral Fracture

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Distal femur or femoral shaft fracture requiring surgery * Evaluation and treatment at UCSD * Age 18 years or older * Ability to understand the content of the patient information/Informed Consent Form * Signed and dated IRB-approved written informed consent Exclusion Criteria: * Any not medically managed severe systemic disease * their doctor has decided that it is in the patient's best interest to receive a different method of fixation * Their doctor has determined that the patient has a condition that would make them unsuitable for participation in the study * Pregnancy or women planning to conceive within the subject participation period (1 year) note: pregnancy will be self-reported and no test will be performed to test for it * Prisoner * Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study

Outcomes

Primary Outcomes

Healing Rates

Time frame: 2 years

Secondary Outcomes

Pain Score (0-10,0=no pain, 10=most severe)

Time frame: 1 year

Number of Complications