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Search / Trial NCT06032299

Dual Implant Versus Single Implant Distal End of Femur

Launched by MAYO CLINIC · Sep 2, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating whether using two implants instead of one for fixing fractures in the lower part of the thigh bone (femur) leads to better results. The study is open to anyone aged 21 and older who has a specific type of femur fracture that can be treated within 72 hours after arriving at the hospital. To participate, patients should have been able to walk before the injury and be able to provide consent, either themselves or through a family member.

Participants in this trial will receive either one or two implants to help stabilize their fracture. They will be closely monitored throughout the process to see how well each method works. It's important to note that individuals with certain conditions, like major fractures in the same leg, active infections, or severe cognitive impairments, won't be eligible to join. This study aims to help improve treatment options for femur fractures, and your involvement could contribute valuable information to this field.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Femur fracture distal to the femoral diaphysis.
  • Operative treatment within 72 hours of presenting to the treating hospital.
  • Patient was previously ambulatory.
  • Fracture amendable to either single or dual implant fixation.
  • Informed consent can be obtained from the patient, family member, or power of attorney.
  • Exclusion Criteria:
  • Associated major lower extremity fracture.
  • Ongoing infection.
  • History of metabolic bone disease (Paget's, etc).
  • Pathologic fracture.
  • Open fracture.
  • Severe cognitive impairment (Six Item Screener with 3 or more errors).
  • Stage 5 Parkinson's disease.
  • Significant femoral bone loss requiring planned staged bone grafting.
  • Vascular injury.

About Mayo Clinic

Mayo Clinic is a renowned nonprofit medical practice and research institution dedicated to providing comprehensive healthcare and advancing medical knowledge through innovative research and education. With a commitment to patient-centered care, Mayo Clinic conducts numerous clinical trials aimed at exploring new therapies and improving treatment outcomes across various disciplines. Leveraging a multidisciplinary approach, the institution collaborates with leading experts and cutting-edge technology to ensure rigorous scientific standards and ethical practices in all its research endeavors. Through its trials, Mayo Clinic seeks to translate breakthroughs in science into tangible benefits for patients, fostering advancements in medicine that enhance health and quality of life.

Locations

Rochester, Minnesota, United States

Patients applied

0 patients applied

Trial Officials

Brandon Yuan, MD

Principal Investigator

Mayo Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported