An interventional study of Single distal femur implant and Dual distal femur implants in Distal Femur Fracture, sponsored by University of Utah. Enrolling by invitation at 5 sites in United States. Open to participants aged 60 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by University of Utah · Not applicable, Interventional, and Treatment
The investigators overall study objective is to determine the difference in outcomes for patients over 60 years of age with a displaced distal femur fracture treated with dual distal femur implants (dual plate or IMN/plate) vs. a single distal femur implant (plate or IMN).
The incidence of distal femur fractures in elderly patients continues to increase, most recently having an incidence of 8.7/100,000/year. This trend likely accompanies the aging population and the increased rates of knee arthroplasty. While these fractures are far less common than geriatric hip fractures, distal femur fractures present similar treatment challenges. Elderly distal femur fractures tend to occur in compromised hosts with poor bone mineral density. Similar to geriatric hip fractures, care emphasizes early mobilization to avoid the complications associated recumbency, including pneumonia, pressure sores, and venous thromboembolism. These patients are often unable to mobilize with restricted weight bearing, which places significant stress on the fixation construct. As a result, elderly patients with distal femur fractures can have high rates of morbidity and mortality.
Despite several prior studies reporting one year mortality greater than 20%, elderly distal femur fractures do not receive the same attention as geriatric hip fractures. These patient injuries are likely similar in terms of their age and comorbidities while having the same issues with post-operative mobility. Therefore, it makes sense that geriatric distal femur fracture patients and geriatric hip fracture patients have similar mortality rates. Investigators recently reported significantly greater in-hospital mortality in geriatric distal femur fractures as compared to geriatric hip fractures. A recent study of the US Medicare database is the largest study on geriatric distal femur fractures in the literature, and the overall mortality of 18.5% is similar to several prior studies ranging from 13-38%.
Distal femur fractures have traditionally been treated with operative fixation using either a lateral plate or an intramedullary nail. Advances in plate and nail technology allow for distal femur fractures to be stabilized with minimal soft tissue dissection. While recent studies suggest that early weight bearing can be tolerated with low failure rates, many surgeons continue to institute weight-bearing restrictions for osteopenic patients treated with operative fixation. Nonunion rates for operatively treated distal femur fractures have been reported to be as high as 20% in large series, leading to additional surgery to achieve union. These limitations with operative fixation have led surgeons to investigate the utility of supplementing the fixation with additional plates and/or nails.
Since many surgeons may not allow early weight bearing in osteopenic patients with operatively treated distal femur fractures, dual plating of the distal femur and locked plate/IMN combinations have become increasingly popular. Biomechanical studies have demonstrated increased torsional stiffness and axial stiffness in dual plate and plate/nail constructs as compared to single implant. A recent meta-analysis by other investigators has further demonstrated dual implants for distal femur fractures to have a low complication rate (5% nonunion) as compared to prior evidence of single implant fixation (0-25% nonunion).
In the recent study, authors reported a trend toward less one year mortality in patients treated with distal femoral replacement (DFR) (13.8%) as compared to operative fixation (22.6%) despite finding similar mortality rates at 90 days post-operatively. Since the complication rate was significantly greater in the DFR cohort, this one year mortality benefit is presumably related to early patient weight bearing after DFR that may not be permitted as frequently with operative fixation. Additionally, patients with a DFR may achieve more early mobility than operatively treated patients who are permitted immediate weight bearing due to enhanced stability in the DFR construct. Using dual implants to treat distal femur fractures may allow patients to achieve early mobility and similar mortality as a DFR patients, but have fewer post-surgical complications and less cost than a DFR.
The investigators overall study aim is to determine the difference in outcomes for patients over 60 years of age with a displaced distal femur fracture treated with dual distal femur implants (dual plate or IMN/plate) vs. a single distal femur implant (plate or IMN).
Exclusion Criteria:
Single implant constructs will be either a retrograde intramedullary nail with interlocking screws or a single plate and screw construct.
Procedure: Single 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.
Procedure: Dual distal femur implants
Single implant fixation
Dual implant fixation
Enrollment rate
Feasibility, defined by enrollment rate (80 patients across five sites)
Time frame: 12-months, post-surgery
Protocol adherence
Feasibility, defined by protocol adherence (≥90%)
Time frame: 12-months, post-surgery
Follow-up retention
Feasibility, defined by follow-up retention (≥85% at 12 months)
Time frame: 12-months, post-surgery
Data completeness
Feasibility, defined by data completeness (≥90%) for key secondary outcomes
Time frame: 12-months, post-surgery
Activity Measure for Post-Acute Care (AM-PAC)
Activity Measure for Post-Acute Care (AM-PAC) Basic Mobility Short Form. Use 6 questions to assess functional outcomes of patients in post-acute care settings.
Time frame: Immediately at the day of discharge after the surgery
Activity Measure for Post-Acute Care (AM-PAC)
Activity Measure for Post-Acute Care (AM-PAC) Basic Mobility Short Form. Use 6 questions to assess functional outcomes of patients in post-acute care settings.
Time frame: 2-weeks, post-surgery
Activity Measure for Post-Acute Care (AM-PAC)
Activity Measure for Post-Acute Care (AM-PAC) Basic Mobility Short Form. Use 6 questions to assess functional outcomes of patients in post-acute care settings.
Time frame: 6-weeks, post-surgery
Activity Measure for Post-Acute Care (AM-PAC)
Activity Measure for Post-Acute Care (AM-PAC) Basic Mobility Short Form. Use 6 questions to assess functional outcomes of patients in post-acute care settings.
Time frame: 3-months, post surgery
Activity Measure for Post-Acute Care (AM-PAC)
Activity Measure for Post-Acute Care (AM-PAC) Basic Mobility Short Form. Use 6 questions to assess functional outcomes of patients in post-acute care settings.
Time frame: 6-months, post-surgery
Activity Measure for Post-Acute Care (AM-PAC)
Activity Measure for Post-Acute Care (AM-PAC) Basic Mobility Short Form. Use 6 questions to assess functional outcomes of patients in post-acute care settings.
Time frame: 12-months, post-surgery
Timed Up and Go (TUG) Test
The Timed Up and Go (TUG) test measures, in seconds, the time an individual takes to stand up from a chair, walk 3 meters, turn, walk back, and sit down. Generally, under 10 seconds is normal, while scores 12-14 seconds indicate a high fall risk and reduced mobility.
Time frame: 6-weeks, post-surgery
Timed Up and Go (TUG) Test
The Timed Up and Go (TUG) test measures, in seconds, the time an individual takes to stand up from a chair, walk 3 meters, turn, walk back, and sit down. Generally, under 10 seconds is normal, while scores 12-14 seconds indicate a high fall risk and reduced mobility.
Time frame: 3-months, post-surgery
Timed Up and Go (TUG) Test
The Timed Up and Go (TUG) test measures, in seconds, the time an individual takes to stand up from a chair, walk 3 meters, turn, walk back, and sit down. Generally, under 10 seconds is normal, while scores 12-14 seconds indicate a high fall risk and reduced mobility.
Time frame: 6-months, post-surgery
Timed Up and Go (TUG) Test
The Timed Up and Go (TUG) test measures, in seconds, the time an individual takes to stand up from a chair, walk 3 meters, turn, walk back, and sit down. Generally, under 10 seconds is normal, while scores 12-14 seconds indicate a high fall risk and reduced mobility.
Time frame: 12-months, post-surgery
Patient Reported Outcomes Measurement Information System, Physical Function, Computerized Adaptive Testing (PROMIS Physical Function CAT)
The PROMIS Physical Function T-score is a standardized score derived from a patient's responses. The T-score has a mean of 50 and a standard deviation of 10, based on a reference population (typically the U.S. general population or a specific clinical group). A T-score above 50 indicates better-than-average physical function. A T-score below 50 indicates below-average physical function.
Time frame: 2-weeks, post-surgery
Patient Reported Outcomes Measurement Information System, Physical Function, Computerized Adaptive Testing (PROMIS Physical Function CAT)
The PROMIS Physical Function T-score is a standardized score derived from a patient's responses. The T-score has a mean of 50 and a standard deviation of 10, based on a reference population (typically the U.S. general population or a specific clinical group). A T-score above 50 indicates better-than-average physical function. A T-score below 50 indicates below-average physical function.
Time frame: 6-weeks, post-surgery
Patient Reported Outcomes Measurement Information System, Physical Function, Computerized Adaptive Testing (PROMIS Physical Function CAT)
The PROMIS Physical Function T-score is a standardized score derived from a patient's responses. The T-score has a mean of 50 and a standard deviation of 10, based on a reference population (typically the U.S. general population or a specific clinical group). A T-score above 50 indicates better-than-average physical function. A T-score below 50 indicates below-average physical function.
Time frame: 12-weeks, post-surgery
Patient Reported Outcomes Measurement Information System, Physical Function, Computerized Adaptive Testing (PROMIS Physical Function CAT)
The PROMIS Physical Function T-score is a standardized score derived from a patient's responses. The T-score has a mean of 50 and a standard deviation of 10, based on a reference population (typically the U.S. general population or a specific clinical group). A T-score above 50 indicates better-than-average physical function. A T-score below 50 indicates below-average physical function.
Time frame: 24-weeks, post-surgery
Patient Reported Outcomes Measurement Information System, Physical Function, Computerized Adaptive Testing (PROMIS Physical Function CAT)
The PROMIS Physical Function T-score is a standardized score derived from a patient's responses. The T-score has a mean of 50 and a standard deviation of 10, based on a reference population (typically the U.S. general population or a specific clinical group). A T-score above 50 indicates better-than-average physical function. A T-score below 50 indicates below-average physical function.
Time frame: 52-weeks, post-surgery
Patient Reported Outcomes Measurement Information System-29 (PROMIS-29)
Patient-reported outcome tool measuring health across seven core domains (physical function, anxiety, depression, fatigue, sleep disturbance, pain interference, and social roles) using 29 items, plus a 0-10 pain intensity rating. Most domains are expressed as T-scores, where 50 is the average for the US general population with a standard deviation (SD) of 10. Higher scores mean "more" of the domain.
Time frame: 2-weeks, post-surgery
Patient Reported Outcomes Measurement Information System-29 (PROMIS-29)
Patient-reported outcome tool measuring health across seven core domains (physical function, anxiety, depression, fatigue, sleep disturbance, pain interference, and social roles) using 29 items, plus a 0-10 pain intensity rating. Most domains are expressed as T-scores, where 50 is the average for the US general population with a standard deviation (SD) of 10. Higher scores mean "more" of the domain.
Time frame: 6-weeks, post-surgery
Patient Reported Outcomes Measurement Information System-29 (PROMIS-29)
Patient-reported outcome tool measuring health across seven core domains (physical function, anxiety, depression, fatigue, sleep disturbance, pain interference, and social roles) using 29 items, plus a 0-10 pain intensity rating. Most domains are expressed as T-scores, where 50 is the average for the US general population with a standard deviation (SD) of 10. Higher scores mean "more" of the domain.
Time frame: 12-weeks, post-surgery
Patient Reported Outcomes Measurement Information System-29 (PROMIS-29)
Patient-reported outcome tool measuring health across seven core domains (physical function, anxiety, depression, fatigue, sleep disturbance, pain interference, and social roles) using 29 items, plus a 0-10 pain intensity rating. Most domains are expressed as T-scores, where 50 is the average for the US general population with a standard deviation (SD) of 10. Higher scores mean "more" of the domain.
Time frame: 24-weeks, post-surgery
Patient Reported Outcomes Measurement Information System-29 (PROMIS-29)
Patient-reported outcome tool measuring health across seven core domains (physical function, anxiety, depression, fatigue, sleep disturbance, pain interference, and social roles) using 29 items, plus a 0-10 pain intensity rating. Most domains are expressed as T-scores, where 50 is the average for the US general population with a standard deviation (SD) of 10. Higher scores mean "more" of the domain.
Time frame: 52-weeks, post-surgery
Infections
Incidents of infections (CDC criteria)
Time frame: 3-months, post-surgery
Readmissions
Incidents of 90-day readmissions
Time frame: 3-months, post-surgery
Complications
Incidents of mortality
Time frame: 3-months, post-surgery
Complications
Incidents of mortality, nonunion, implant failure, unplanned reoperation
Time frame: 12-months, post-surgery
Plan to share: No
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