Distal Femur FractureNCT05292313
Dual Implant Versus Single Implant Distal End of Femur
A study testing Single distal femur implant and Dual distal femur implants in people with Distal Femur Fracture, run by University of Utah at 5 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Distal Femur Fracture
- What is being tested?
- Single distal femur implant and Dual distal femur implants
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 5 sitesUnited States
- Study dates
- 14 Mar 2022to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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),
Show all 11Show fewer
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites
University of Pittsburg Medical Center - Harrisburg
Harrisburg, Pennsylvania, 17101
New York University
New York, New York, 10012
Oregon Health & Science Center
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
University of Utah Orthopaedic Center
Salt Lake City, Utah, 84112
About this study
Official title: Pilot for Dual Implant Versus Single Implant Distal End of Femur (pDISIDE 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).
Read the detailed description
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).
- Conditions
- Distal Femur Fracture
- Being tested
- Single distal femur implant, Dual distal femur implants
- Keywords
- Distal Femur Fracture, Dual distal femur implants, Single distal femur implant
- Medical subject headings
- Femoral Fractures, Distal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single distal femur implantProcedure or surgery
Single implant fixation
Dual distal femur implantsProcedure or surgery
Dual implant fixation
| Study group | Role | What they receive |
|---|---|---|
| Single distal femur implant | Other | Single implant constructs will be either a retrograde intramedullary nail with interlocking screws or a single plate and screw construct. Receives: Procedure: Single distal femur implant |
| Dual distal femur implants | Other | 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. Receives: Procedure: Dual distal femur implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate
Feasibility, defined by enrollment rate (80 patients across five sites)
Measured: 12-months, post-surgery
Protocol adherence
Feasibility, defined by protocol adherence (≥90%)
Measured: 12-months, post-surgery
Follow-up retention
Feasibility, defined by follow-up retention (≥85% at 12 months)
Measured: 12-months, post-surgery
Data completeness
Feasibility, defined by data completeness (≥90%) for key secondary outcomes
Measured: 12-months, post-surgery
Secondary outcomes (24)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 52-weeks, post-surgery
Infections
Incidents of infections (CDC criteria)
Measured: 3-months, post-surgery
Readmissions
Incidents of 90-day readmissions
Measured: 3-months, post-surgery
Complications
Incidents of mortality
Measured: 3-months, post-surgery
Complications
Incidents of mortality, nonunion, implant failure, unplanned reoperation
Measured: 12-months, post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start14 Mar 2022
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Distal Femur FractureStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Haller, University of Utah
- Investigators
- Justin Haller, M.D., Principal investigator, University of Utah Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292313
- Sponsor's protocol ID
- 149119
- Status last verified
- Apr 2026
- First submitted
- 14 Mar 2022
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haller J, Achebe CC, Oman G, Konda S, Garner M, Yuan B, Marchand LS, DeKeyser GJ. Dual versus single implant fixation for geriatric distal femur fractures: protocol for a randomised, controlled pilot study at five US level 1 trauma centres. BMJ Open. 2026 May 26;16(5):e113559. doi: 10.1136/bmjopen-2025-113559.
PubMed 42191186
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot for Dual Implant Versus Single Implant Distal End of Femur (pDISIDE Femur)
- ClinicalTrials.gov ID
- NCT05292313
- Acronym / sponsor ID
- 149119
- Conditions
- Distal Femur Fracture
- Keywords
- Distal Femur Fracture, Dual distal femur implants, Single distal femur implant
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 23 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single distal femur implant | Other | Procedure: Single distal femur implantSingle implant constructs will be either a retrograde intramedullary nail with interlocking screws or a single plate and screw construct. |
| Dual distal femur implants | Other | Procedure: Dual distal femur implantsDual 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. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (11 listed)
- Associated major lower extremity fracture,
- Ongoing infection,
- History of metabolic bone disease (Paget's, etc),
- Pathologic fracture,
- Gustilo-Anderson Type 3B/3C open fractures,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single distal femur implantSingle implant fixation | Procedure or surgery | Single distal femur implant |
| Dual distal femur implantsDual implant fixation | Procedure or surgery | Dual distal femur implants |
Primary outcome
Enrollment rate
Time frame: 12-months, post-surgery
Feasibility, defined by enrollment rate (80 patients across five sites)
Protocol adherence
Time frame: 12-months, post-surgery
Feasibility, defined by protocol adherence (≥90%)
Follow-up retention
Time frame: 12-months, post-surgery
Feasibility, defined by follow-up retention (≥85% at 12 months)
Data completeness
Time frame: 12-months, post-surgery
Feasibility, defined by data completeness (≥90%) for key secondary outcomes
24 secondary outcomes
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)
Time frame: 2-weeks, post-surgery
Activity Measure for Post-Acute Care (AM-PAC)
Time frame: 6-weeks, post-surgery
Activity Measure for Post-Acute Care (AM-PAC)
Time frame: 3-months, post surgery
Activity Measure for Post-Acute Care (AM-PAC)
Time frame: 6-months, post-surgery
Activity Measure for Post-Acute Care (AM-PAC)
Time frame: 12-months, post-surgery
Timed Up and Go (TUG) Test
Time frame: 6-weeks, post-surgery
Timed Up and Go (TUG) Test
Time frame: 3-months, post-surgery
Timed Up and Go (TUG) Test
Time frame: 6-months, post-surgery
Timed Up and Go (TUG) Test
Time frame: 12-months, post-surgery
Patient Reported Outcomes Measurement Information System, Physical Function, Computerized Adaptive Testing (PROMIS Physical Function CAT)
Time frame: 2-weeks, post-surgery
Patient Reported Outcomes Measurement Information System, Physical Function, Computerized Adaptive Testing (PROMIS Physical Function CAT)
Time frame: 6-weeks, post-surgery
Patient Reported Outcomes Measurement Information System, Physical Function, Computerized Adaptive Testing (PROMIS Physical Function CAT)
Time frame: 12-weeks, post-surgery
Patient Reported Outcomes Measurement Information System, Physical Function, Computerized Adaptive Testing (PROMIS Physical Function CAT)
Time frame: 24-weeks, post-surgery
Patient Reported Outcomes Measurement Information System, Physical Function, Computerized Adaptive Testing (PROMIS Physical Function CAT)
Time frame: 52-weeks, post-surgery
Patient Reported Outcomes Measurement Information System-29 (PROMIS-29)
Time frame: 2-weeks, post-surgery
Patient Reported Outcomes Measurement Information System-29 (PROMIS-29)
Time frame: 6-weeks, post-surgery
Patient Reported Outcomes Measurement Information System-29 (PROMIS-29)
Time frame: 12-weeks, post-surgery
Patient Reported Outcomes Measurement Information System-29 (PROMIS-29)
Time frame: 24-weeks, post-surgery
Patient Reported Outcomes Measurement Information System-29 (PROMIS-29)
Time frame: 52-weeks, post-surgery
Infections
Time frame: 3-months, post-surgery
Readmissions
Time frame: 3-months, post-surgery
Complications
Time frame: 3-months, post-surgery
Complications
Time frame: 12-months, post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 42191186Haller J, Achebe CC, Oman G, Konda S, Garner M, Yuan B, Marchand LS, DeKeyser GJ. Dual versus single implant fixation for geriatric distal femur fractures: protocol for a randomised, controlled pilot study at five US level 1 trauma centres. BMJ Open. 2026 May 26;16(5):e113559. doi: 10.1136/bmjopen-2025-113559.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Justin Haller, M.D. principal investigator
University of Utah Orthopaedics
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single distal femur implant and Dual distal femur implants in people with Distal Femur Fracture, run by University of Utah at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rate (time frame: 12-months, post-surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05292313, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.