Geriatric Distal Femur
ConditionArticular Fractures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorWake Forest University Health Sciences
About this trial
The goal of this clinical trial is to compare two types of surgical fixation in patients with specific kinds of distal femur fractures. The main questions it aims to answer is which operation for distal femur fractures is better for efficient return to work and everyday activities.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age greater than or equal to 55 years
Surgically treated displaced distal femur extra articular or complete articular fractures
Disqualifiers
Patients with injury features that preclude treatment with 2 implants
Patients unlikely to follow-up due to homelessness, or planning follow up at another institution
Body Mass Index (BMI) > 40
Injury due to ground level fall
Trial design
Design model
Parallel
Treatments tested in this trial
Single Implant Fixation
Procedure/SurgeryLateral precontoured 4.5 mm distal femur plate or an intramedullary nail at the surgeon's discretion. Standard-of-care techniques will be used by the surgeon for fracture reduction and implant placement.
Dual Implant Fixation
Procedure/SurgeryLateral precontoured distal femur plate and either (1) an intramedullary nail or (2) a medial plate. The medial plate must span the extra-articular portion of the fracture and must have stiffness of a 3.5 mm reconstruction plate, 3.5 mm limited contact dynamic compression plate, or greater.
Treatment groups
256 Participants
are divided into 2 treatment groupsGroup A: Single Implant FixationOther 1 intervention
Group B: Dual Implant FixationOther 1 intervention
Trial outcomes
Primary outcomes
1
Number of Unions
Union, as determined by the treating surgeon, will be assessed via radiographs and documented as a dichotomous outcome (yes/no), and time to union will also be captured. Nonunion will be captured via surgeon diagnosis or return to the operating room for nonunion treatment.
Time frame
6-week, 3, 6, 12 months2
Total Surgical Time - Reoperations
The total surgical time during any reoperations will be collected from the medical record.
Time frame
6-week, 3, 6, 12 months3
Number of Reoperations
Details regarding reoperations will also be collected, whether or not the operation results in an inpatient admission.
Time frame
6-week, 3, 6, 12 monthsSecondary outcomes
1
Number of Resource Utilizations
Healthcare utilization, including all hospitalizations, emergency department visits, clinic visits, imaging, and physical therapy sessions after the index stay following injury will be documented at all follow-up visits.
Time frame
6-week, 3, 6, 12 month2
Return to Work - International Physical Activity Questionnaire (IPAQ) Scores
Completion of the International Physical Activity Questionnaire (IPAQ). The IPAQ is a validated, self-report measure that captures detailed information about participation in a wide range of physical activities, including the number of days and amount of time spent in the previous 7 days. Responses for each type of physical activity are then transformed into the number of Metabolic Equivalent for Tasks (METs), and a METs/week is calculated for each patient. To get a continuous variable score from the IPAQ (MET minutes a week) it is considered walking to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS. Higher scores meaning more activity.
Time frame
Week 63
Return to Work - International Physical Activity Questionnaire (IPAQ) Scores
Completion of the International Physical Activity Questionnaire (IPAQ). The IPAQ is a validated, self-report measure that captures detailed information about participation in a wide range of physical activities, including the number of days and amount of time spent in the previous 7 days. Responses for each type of physical activity are then transformed into the number of Metabolic Equivalent for Tasks (METs), and a METs/week is calculated for each patient. To get a continuous variable score from the IPAQ (MET minutes a week) it is considered walking to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS. Higher scores meaning more activity.
Time frame
Month 34
Return to Work - International Physical Activity Questionnaire (IPAQ) Scores
Completion of the International Physical Activity Questionnaire (IPAQ). The IPAQ is a validated, self-report measure that captures detailed information about participation in a wide range of physical activities, including the number of days and amount of time spent in the previous 7 days. Responses for each type of physical activity are then transformed into the number of Metabolic Equivalent for Tasks (METs), and a METs/week is calculated for each patient. To get a continuous variable score from the IPAQ (MET minutes a week) it is considered walking to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS. Higher scores meaning more activity.
Time frame
Month 6Sponsors and contacts
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Source ClinicalTrials.gov