New method for fixing femoral fractures
Utilizing the Retrograde Femoral Nail-Advanced for Fixation of Distal Femur and Femoral Shaft Fractures: A Prospective Case Series
This study is testing a new type of implant for fixing femur fractures in adults to see if it helps them heal better and have fewer complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT05680987 on ClinicalTrials.gov |
What this trial studies
This project involves a prospective and retrospective case series design focusing on patients aged 18 and older with distal femur or femoral shaft fractures requiring surgical fixation. Participants will receive the RFN-advanced Retrograde Femoral Nailing System implant, and data on their functional status, healing rates, complication rates, and pain levels will be collected over three years. The goal is to evaluate the effectiveness of this new design in reducing complications associated with current femoral nail systems.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a distal femur or femoral shaft fracture requiring surgical intervention.
Not a fit: Patients with severe systemic diseases or those for whom alternative fixation methods are deemed more appropriate may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved healing outcomes and reduced complications for patients with femoral fractures.
How similar studies have performed: While this approach is novel, previous studies have indicated the need for improved fixation methods due to high complication rates with existing designs.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Diego, California
- University of California, San Diego — San Diego, California, United States (Recruiting)
Study contacts
- Study coordinator: Dominic Baun, MS
- Email: jbaun@health.ucsd.edu
- Phone: 858-534-8268
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.