Back to resultsDual Implant Versus Single Implant Distal End of Femur
Primary Purpose
Femur Fracture
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Single Distal Femur Implant
Dual Distal Femur Implant
Sponsored by
About this trial
This is an interventional treatment trial for Femur Fracture
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.
Sites / Locations
- Mayo Clinic Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Single Distal Femur Implant Group
Dual Distal Femur Implant Group
Arm Description
Subjects will receive one of two types of implants for the distal femur fracture. The single implant will be either a plate and screws or a rod. The type of single implant used will be determined by the surgeon based on the characteristics of the fracture.
Subjects will receive two implants for fixation of the distal femur fracture. The dual implant will be either 2 plates with screws or a plate with screws and a rod. The type of dual implant used will be determined by the surgeon based on the characteristics of the fracture.
Outcomes
Primary Outcome Measures
Number of study-eligible subjects
Total number of subjects to be enrolled in the study
Secondary Outcome Measures
Operative times
Total recorded amount of time in minutes to complete the surgery
Blood loss
Total amount of surgical blood loss, reported in mL.
Hospitalization days
Total number of days a subject requires hospitalization after surgery
Early post-surgical complications
Number of subjects to experience venous thromboembolism (VTE), cardiopulmonary, and/or infectious complications after surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06032299
Brief Title
Dual Implant Versus Single Implant Distal End of Femur
Official Title
Pilot for Dual Implant Versus Single Implant Distal End of Femur (pDISIDE Femur)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This research study is being conducted to examine the effect of two versus one fixation device for fixation of distal femur fractures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femur Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single Distal Femur Implant Group
Arm Type
Active Comparator
Arm Description
Subjects will receive one of two types of implants for the distal femur fracture. The single implant will be either a plate and screws or a rod. The type of single implant used will be determined by the surgeon based on the characteristics of the fracture.
Arm Title
Dual Distal Femur Implant Group
Arm Type
Experimental
Arm Description
Subjects will receive two implants for fixation of the distal femur fracture. The dual implant will be either 2 plates with screws or a plate with screws and a rod. The type of dual implant used will be determined by the surgeon based on the characteristics of the fracture.
Intervention Type
Procedure
Intervention Name(s)
Single Distal Femur Implant
Intervention Description
Single implant constructs will be either a retrograde intramedullary nail with interlocking screws or a single plate and screw construct.
Intervention Type
Procedure
Intervention Name(s)
Dual Distal Femur Implant
Intervention Description
Dual implant constructs will either be an intramedullary nail with an additional plate and screw construct or dual (two plates in any orientation) plate and screw construct.
Primary Outcome Measure Information:
Title
Number of study-eligible subjects
Description
Total number of subjects to be enrolled in the study
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Operative times
Description
Total recorded amount of time in minutes to complete the surgery
Time Frame
Duration of surgery, approximately 2-4 hours
Title
Blood loss
Description
Total amount of surgical blood loss, reported in mL.
Time Frame
Duration of surgery, approximately 2-4 hours
Title
Hospitalization days
Description
Total number of days a subject requires hospitalization after surgery
Time Frame
approximately 2-3 days
Title
Early post-surgical complications
Description
Number of subjects to experience venous thromboembolism (VTE), cardiopulmonary, and/or infectious complications after surgery
Time Frame
2 weeks post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brandon Yuan, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Dual Implant Versus Single Implant Distal End of Femur
We'll reach out to this number within 24 hrs