Retrograde Femoral Nail-Advanced Outcomes for Fixation of Distal Femur and Femoral Shaft Fractures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RFN-Advanced Retrograde Femoral Nailing System.
- Who it may be relevant to
- Registry conditions: Femoral Fracture. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Utilizing the Retrograde Femoral Nail-Advanced for Fixation of Distal Femur and Femoral Shaft Fractures: A Prospective Case Series
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.
Interventions
- Procedure RFN-Advanced Retrograde Femoral Nailing System
RFN-Advanced Retrograde Femoral Nailing System for patients with a distal femur or femoral shaft fracture requiring surgery
Primary outcome measures
- Healing Rates [Time frame: 2 years]
Secondary outcome measures (2)
- Pain Score (0-10,0=no pain, 10=most severe) [Time frame: 1 year]
- Number of Complications [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- University of California, San Diego — San Diego
Identifiers
NCT: NCT05680987 · 210669