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Enrolling by Invitation

NCT Number: NCT05292313

Dual Implant Versus Single Implant Distal End of Femur

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).

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Key information

Conditions

Distal Femur Fracture Femoral Fractures Femoral Fractures, Distal Fractures, Bone Leg Injuries Wounds and Injuries

Age range

60 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic, Rochester, Minnesota, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient age 60 years or greater,
  • 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,
  • Displaced fracture (>2.5mm displacement, native or periprosthetic)

Exclusion criteria

  • Associated major lower extremity fracture,
  • Ongoing infection,
  • History of metabolic bone disease (Paget's, etc),
  • Pathologic fracture,
  • Gustilo-Anderson Type 3B/3C open fractures,
  • 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,
  • Bilateral femur fractures,
  • Unable to follow-up at treating institution for 12 months

Treatment and study plan

Single Distal Femur Implant

Procedure

Single implant fixation

Dual distal femur implants

Procedure

Dual implant fixation

Primary outcomes

  1. Enrollment rate

    Time frame: 12-months, post-surgery

    Feasibility, defined by enrollment rate (80 patients across five sites)

  2. Protocol adherence

    Time frame: 12-months, post-surgery

    Feasibility, defined by protocol adherence (≥90%)

  3. Follow-up retention

    Time frame: 12-months, post-surgery

    Feasibility, defined by follow-up retention (≥85% at 12 months)

  4. Data completeness

    Time frame: 12-months, post-surgery

    Feasibility, defined by data completeness (≥90%) for key secondary outcomes

Secondary outcomes

  1. Activity Measure for Post-Acute Care (AM-PAC)

    Time frame: Immediately at the day of discharge after the surgery

    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.

  2. Activity Measure for Post-Acute Care (AM-PAC)

    Time frame: 2-weeks, post-surgery

    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.

  3. Activity Measure for Post-Acute Care (AM-PAC)

    Time frame: 6-weeks, post-surgery

    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.

  4. Activity Measure for Post-Acute Care (AM-PAC)

    Time frame: 3-months, post surgery

    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.

  5. Activity Measure for Post-Acute Care (AM-PAC)

    Time frame: 6-months, post-surgery

    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.

  6. Activity Measure for Post-Acute Care (AM-PAC)

    Time frame: 12-months, post-surgery

    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.

  7. Timed Up and Go (TUG) Test

    Time frame: 6-weeks, post-surgery

    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.

  8. Timed Up and Go (TUG) Test

    Time frame: 3-months, post-surgery

    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.

  9. Timed Up and Go (TUG) Test

    Time frame: 6-months, post-surgery

    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.

  10. Timed Up and Go (TUG) Test

    Time frame: 12-months, post-surgery

    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.

  11. Patient Reported Outcomes Measurement Information System, Physical Function, Computerized Adaptive Testing (PROMIS Physical Function CAT)

    Time frame: 2-weeks, post-surgery

    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.

  12. Patient Reported Outcomes Measurement Information System, Physical Function, Computerized Adaptive Testing (PROMIS Physical Function CAT)

    Time frame: 6-weeks, post-surgery

    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.

  13. Patient Reported Outcomes Measurement Information System, Physical Function, Computerized Adaptive Testing (PROMIS Physical Function CAT)

    Time frame: 12-weeks, post-surgery

    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.

  14. Patient Reported Outcomes Measurement Information System, Physical Function, Computerized Adaptive Testing (PROMIS Physical Function CAT)

    Time frame: 24-weeks, post-surgery

    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.

  15. Patient Reported Outcomes Measurement Information System, Physical Function, Computerized Adaptive Testing (PROMIS Physical Function CAT)

    Time frame: 52-weeks, post-surgery

    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.

  16. Patient Reported Outcomes Measurement Information System-29 (PROMIS-29)

    Time frame: 2-weeks, post-surgery

    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.

  17. Patient Reported Outcomes Measurement Information System-29 (PROMIS-29)

    Time frame: 6-weeks, post-surgery

    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.

  18. Patient Reported Outcomes Measurement Information System-29 (PROMIS-29)

    Time frame: 12-weeks, post-surgery

    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.

  19. Patient Reported Outcomes Measurement Information System-29 (PROMIS-29)

    Time frame: 24-weeks, post-surgery

    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.

  20. Patient Reported Outcomes Measurement Information System-29 (PROMIS-29)

    Time frame: 52-weeks, post-surgery

    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.

  21. Infections

    Time frame: 3-months, post-surgery

    Incidents of infections (CDC criteria)

  22. Readmissions

    Time frame: 3-months, post-surgery

    Incidents of 90-day readmissions

  23. Complications

    Time frame: 3-months, post-surgery

    Incidents of mortality

  24. Complications

    Time frame: 12-months, post-surgery

    Incidents of mortality, nonunion, implant failure, unplanned reoperation

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 23, 2022
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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