Femur FractureNCT06032299
Dual Implant Versus Single Implant Distal End of Femur
A study testing Single Distal Femur Implant and Dual Distal Femur Implant in people with Femur Fracture, run by Mayo Clinic at 1 site in United States.
Trial summary
This research study is being conducted to examine the effect of two versus one fixation device for fixation of distal femur fractures. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Femur Fracture
- What is being tested?
- Single Distal Femur Implant and Dual Distal Femur Implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2024to Nov 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- Stage 5 Parkinson's disease.
- Significant femoral bone loss requiring planned staged bone grafting.
- Vascular injury.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot for Dual Implant Versus Single Implant Distal End of Femur (pDISIDE Femur)
This research study is being conducted to examine the effect of two versus one fixation device for fixation of distal femur fractures.
- Conditions
- Femur Fracture
- Being tested
- Single Distal Femur Implant, Dual Distal Femur Implant
- Medical subject headings
- Femoral Fractures
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 constructs will be either a retrograde intramedullary nail with interlocking screws or a single plate and screw construct.
Dual Distal Femur ImplantProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Distal Femur Implant Group | Active comparator | Subjects will receive one of two types of implants for the distal femur fracture. The single implant will be either a plate and screws or a rod. The type of single implant used will be determined by the surgeon based on the characteristics of the fracture. Receives: Procedure: Single Distal Femur Implant |
| Dual Distal Femur Implant Group | Experimental | Subjects will receive two implants for fixation of the distal femur fracture. The dual implant will be either 2 plates with screws or a plate with screws and a rod. The type of dual implant used will be determined by the surgeon based on the characteristics of the fracture. Receives: Procedure: Dual Distal Femur Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of study-eligible subjects
Total number of subjects to be enrolled in the study
Measured: Baseline
Secondary outcomes (4)
Operative times
Total recorded amount of time in minutes to complete the surgery
Measured: Duration of surgery, approximately 2-4 hours
Blood loss
Total amount of surgical blood loss, reported in mL.
Measured: Duration of surgery, approximately 2-4 hours
Hospitalization days
Total number of days a subject requires hospitalization after surgery
Measured: approximately 2-3 days
Early post-surgical complications
Number of subjects to experience venous thromboembolism (VTE), cardiopulmonary, and/or infectious complications after surgery
Measured: 2 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start29 Apr 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femur FractureStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brandon James Yuan, Mayo Clinic
- Investigators
- Brandon Yuan, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032299
- Sponsor's protocol ID
- 22-004415
- Status last verified
- Mar 2026
- First submitted
- 2 Sep 2023
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 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
- NCT06032299
- Acronym / sponsor ID
- 22-004415
- Conditions
- Femur Fracture
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 11 Sep 2023 (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.
This research study is being conducted to examine the effect of two versus one fixation device for fixation of distal femur fractures.
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 Group | Active comparator | Procedure: Single Distal Femur ImplantSubjects will receive one of two types of implants for the distal femur fracture. The single implant will be either a plate and screws or a rod. The type of single implant used will be determined by the surgeon based on the characteristics of the fracture. |
| Dual Distal Femur Implant Group | Experimental | Procedure: Dual Distal Femur ImplantSubjects will receive two implants for fixation of the distal femur fracture. The dual implant will be either 2 plates with screws or a plate with screws and a rod. The type of dual implant used will be determined by the surgeon based on the characteristics of the fracture. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- Associated major lower extremity fracture.
- Ongoing infection.
- History of metabolic bone disease (Paget's, etc).
- Pathologic fracture.
- Open fracture.
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 constructs will be either a retrograde intramedullary nail with interlocking screws or a single plate and screw construct. | Procedure or surgery | Single Distal Femur Implant Group |
| Dual Distal Femur ImplantDual 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 or surgery | Dual Distal Femur Implant Group |
Primary outcome
Number of study-eligible subjects
Time frame: Baseline
Total number of subjects to be enrolled in the study
4 secondary outcomes
Operative times
Time frame: Duration of surgery, approximately 2-4 hours
Blood loss
Time frame: Duration of surgery, approximately 2-4 hours
Hospitalization days
Time frame: approximately 2-3 days
Early post-surgical complications
Time frame: 2 weeks 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 10 Mar 2026.
- 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. This study is not recruiting at the moment.
Brandon Yuan, MD principal investigator
Mayo Clinic
1 site 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 Implant in people with Femur Fracture, run by Mayo Clinic at 1 site 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 5 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of study-eligible subjects (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2026.