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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06032299
Other study ID # 22-004415
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 29, 2024
Est. completion date September 2025

Study information

Verified date June 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date September 2025
Est. primary completion date September 2025
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Mayo Clinic Minnesota Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of study-eligible subjects Total number of subjects to be enrolled in the study Baseline
Secondary Operative times Total recorded amount of time in minutes to complete the surgery Duration of surgery, approximately 2-4 hours
Secondary Blood loss Total amount of surgical blood loss, reported in mL. Duration of surgery, approximately 2-4 hours
Secondary Hospitalization days Total number of days a subject requires hospitalization after surgery approximately 2-3 days
Secondary Early post-surgical complications Number of subjects to experience venous thromboembolism (VTE), cardiopulmonary, and/or infectious complications after surgery 2 weeks post-surgery
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