ACTIVE_NOT_RECRUITING

Dual Implant Versus Single Implant Distal End of Femur

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This research study is being conducted to examine the effect of two versus one fixation device for fixation of distal femur fractures.

Official Title

Pilot for Dual Implant Versus Single Implant Distal End of Femur (pDISIDE Femur)

Quick Facts

Study Start:2024-04-29
Study Completion:2026-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06032299

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Femur fracture distal to the femoral diaphysis.
  2. * Operative treatment within 72 hours of presenting to the treating hospital.
  3. * Patient was previously ambulatory.
  4. * Fracture amendable to either single or dual implant fixation.
  5. * Informed consent can be obtained from the patient, family member, or power of attorney.
  1. * Associated major lower extremity fracture.
  2. * Ongoing infection.
  3. * History of metabolic bone disease (Paget's, etc).
  4. * Pathologic fracture.
  5. * Open fracture.
  6. * Severe cognitive impairment (Six Item Screener with 3 or more errors).
  7. * Stage 5 Parkinson's disease.
  8. * Significant femoral bone loss requiring planned staged bone grafting.
  9. * Vascular injury.

Contacts and Locations

Principal Investigator

Brandon Yuan, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic Minnesota
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Brandon Yuan, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-29
Study Completion Date2026-02

Study Record Updates

Study Start Date2024-04-29
Study Completion Date2026-02

Terms related to this study

Additional Relevant MeSH Terms

  • Femur Fracture