Dual Implant Versus Single Implant Distal End of Femur

Sponsor

Mayo Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06032299

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Femur Fracture	Procedure: Single Distal Femur Implant Procedure: Dual Distal Femur Implant	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Single Distal Femur Implant Group 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.	Procedure: Single Distal Femur Implant Single implant constructs will be either a retrograde intramedullary nail with interlocking screws or a single plate and screw construct.
Experimental: Dual Distal Femur Implant Group 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.	Procedure: Dual Distal Femur Implant 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.

Arm

Intervention/Treatment

Active Comparator: Single Distal Femur Implant Group

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.

Procedure: Single Distal Femur Implant

Single implant constructs will be either a retrograde intramedullary nail with interlocking screws or a single plate and screw construct.

Experimental: Dual Distal Femur Implant Group

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.

Procedure: Dual Distal Femur Implant

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.

Outcome Measures

Primary Outcome Measures

Number of study-eligible subjects [Baseline]
Total number of subjects to be enrolled in the study

Secondary Outcome Measures

Operative times [Duration of surgery, approximately 2-4 hours]
Total recorded amount of time in minutes to complete the surgery
Blood loss [Duration of surgery, approximately 2-4 hours]
Total amount of surgical blood loss, reported in mL.
Hospitalization days [approximately 2-3 days]
Total number of days a subject requires hospitalization after surgery
Early post-surgical complications [2 weeks post-surgery]
Number of subjects to experience VTE, cardiopulmonary, and/or infectious complications after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Minnesota	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Brandon Yuan, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Brandon James Yuan, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT06032299

Other Study ID Numbers:

22-004415

First Posted:

Sep 11, 2023

Last Update Posted:

Sep 11, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Femoral Fractures

Study Results

No Results Posted as of Sep 11, 2023