Distal Femur FracturesNCT06944964
Single vs. Dual Implant Fixation for Distal Femur Fractures in Older or Compromised Adults
A study testing Single Implant Fixation (SIF) and Dual Implant Fixation (DIF) in people with Distal Femur Fractures, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.
Trial summary
The goal of this clinical trial is to assess the feasibility of conducting a larger study comparing single implant fixation (SIF) and dual implant fixation (DIF) for treating distal femur fractures (DFF) in older or compromised adults. It will also evaluate the safety and effectiveness of these treatments. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Distal Femur Fractures
- What is being tested?
- Single Implant Fixation (SIF) and Dual Implant Fixation (DIF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Sep 2025to 1 May 2030
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Isolated DFF (native AO/OTA-type A2, A3, C or periprosthetic Lewis and
- Rorabeck type 1, 2) and either:
- Age ≥ 60 years or;
- Age 18-60 years with one or more of:
- Osteoporosis ii. Obesity (Body Mass Index >30) iii. Metaphyseal comminution iv. Diabetes
- Fracture amenable to plating and nailing
Show all 10Show fewer
- Ability to read and speak English or availability of a translator
- Acute fractures (within 14-days of injury)
- No surgeon preference regarding SIF vs. DIF
- Provision of informed consent
Who cannot join
- Candidate for primary or revision arthroplasty (surgeon opinion)
- Periprosthetic fracture with loose implant
- Gustillo grade III open fractures
- Ipsilateral hip implant
- Likely problems, in the judgment of the investigators, with maintaining follow-up (i.e., no fixed address, mentally competent to give consent, etc.)
- Non-ambulatory patients
Show all 10Show fewer
- Multi-trauma patient (Injury Severity Score ≥ 16)
- Lack of bone substance or poor bone-quality which, in the surgeon's judgment, makes fixation impossible
- Any concomitant lower-extremity injury
- Inability to obtain informed consent due to language barrier
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
London Health Sciences Centre
London, Ontario, N6A 5A5
Lawson Health Research Institute, 519-685-8500
Emil Schemitsch, MD, FRCS(C)
- Not yet recruiting
Fraser Orthopaedic Institute
New Westminster, British Columbia
David Cinats, MD, FRCS(C), 604-545-1405
About this study
The goal of this clinical trial is to assess the feasibility of conducting a larger study comparing single implant fixation (SIF) and dual implant fixation (DIF) for treating distal femur fractures (DFF) in older or compromised adults. It will also evaluate the safety and effectiveness of these treatments. The main questions it aims to answer are:
- Can DIF improve patient outcomes compared to SIF in older or compromised adults?
- How feasible is it to recruit and retain participants for this trial?
Read more
Participants will:
- Be randomly assigned to receive either SIF or DIF for their DFF treatment
- Visit the clinic for follow-ups and assessments of their recovery and bone healing, including potential ultrasound imaging for detecting complications like non-union.
Read the detailed description
The Investigators aim to conduct a multi-centre, preliminary RCT to determine the feasibility and inform the design of a definitive trial comparing patient-important outcomes between patients aged 40 years and older with distal femur fractures managed with SIF vs. DIF.
Primary Aim: Evaluate the feasibility of conducting a larger, definitive trial examining outcomes following SIF vs. DIF for DFFs in older or compromised adults. Our primary outcomes for this objective will be 1) recruitment and retention at the participating sites; and 2) site investigator feedback regarding barriers to protocol adherence.
Secondary Aims: Pilot the collection of candidate outcome measures to determine the optimal primary end point and sample size for a definitive trial. Our primary outcome for this objective will be the Oxford Knee Score, and secondary outcomes will include a range of patient-reported quality of life (QOL) measures, and objective clinical measures.
In addition, the study includes an ultrasound sub-study aimed at evaluating the feasibility of using ultrasound imaging to monitor bone healing and detect complications like non-union in patients with DFF.
Participants will be randomly assigned to receive either SIF or DIF, with SIF generally involving a single implant (such as a lateral locked plate or retrograde intramedullary nail) and DIF using a combination of implants (e.g., dual plates or a nail and plate). This randomized design will enable us to assess whether dual implant fixation offers improved clinical outcomes, such as reduced morbidity and faster weight-bearing recovery, compared to the more traditional single implant fixation.
Non-Randomized Participation: The investigators will collect data surrounding the number of eligible patients approached for consent, eligible patients not approached for consent and reason why, along with the proportion of patients who do not consent and reasons why to refine our strategy for the definitive trial. For patients who are excluded due to a lack of clinical equipoise, the investigators will provide the option of participating in a concurrent cohort study.This study will record the same variables as the RCT.
The trial will take place at four major trauma centers across Canada: London Health Sciences Centre - Victoria Hospital, St. Michael's Hospital, Sunnybrook Health Sciences Centre, and Alberta Health Services Centre. Participants will receive follow-up visits at these centers, which will include clinical check-ups, rehabilitation sessions, and imaging assessments to track their recovery progress.
The data gathered from this feasibility study will provide critical insights into the practicality of a larger-scale trial and will help inform future treatment strategies for distal femur fractures.
- Conditions
- Distal Femur Fractures
- Being tested
- Single Implant Fixation (SIF), Dual Implant Fixation (DIF)
- Keywords
- Single Implant Fixation, Dual Implant Fixation, Dual Plate Fixation, Combination nail-plate fixation
- 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 Implant Fixation (SIF)Procedure or surgery
This intervention involves using one implant for fracture fixation. The implant can be either a lateral locked plate or a retrograde intramedullary nail, based on the surgeon's preference.
Dual Implant Fixation (DIF)Procedure or surgery
This intervention involves using two implants for fracture fixation. The combination can be either dual plate fixation (DPF) or combination nail plate fixation (NPF) .
| Study group | Role | What they receive |
|---|---|---|
| Group A (Control): Single Implant Fixation (SIF) | Active comparator | Patients in this arm will undergo fixation of distal femur fractures using a single implant, which could be a lateral locked plate or a retrograde intramedullary nail. Receives: Procedure: Single Implant Fixation (SIF) |
| Group B (Experimental): Dual Implant Fixation (DIF) | Active comparator | Patients in this arm will undergo fixation using dual implants, either dual plate fixation or a combination of nail and plate fixation. Receives: Procedure: Dual Implant Fixation (DIF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Outcomes - Recruitment
Recruitment - 1) Recruitment (number of patients enrolled per-month). Success will be considered as each site enrolling a minimum mean of 0.6 patients per-month. This is a conservative estimate based on our previous trials in similar populations, and we expect that each site will screen a minimum of twice this number.
- Number of patients enrolled per month
- Success if each site able to enroll mean of 0.6 patients per month
Measured: Through study completion, an average of 1 year.
Feasibility Outcomes - Retention
Retention - (proportion of patients that complete one-year follow-up). Success will be considered a minimum of 85% of patients with complete one-year data.
- Proportion of patients that complete 1 year follow up
- Success: 85%
Measured: Through study completion, an average of 1 year.
Functional Ability
Via the validated Oxford Knee Score. It ranges from 0 to 48, with higher scores indicating better outcomes (i.e., less pain and better function).
Measured: 2 year
Secondary outcomes (15)
Pain rating
Via the numeric pain rating scale (NRS). 0-10; higher scores = worse pain.
Measured: 2 years
Functional ability
Via the PROMIS-Physical Function Short. Higher = better for function domains
Higher = worse for symptom domains (e.g., pain, fatigue).
Form.
Measured: 2 years
Weight-bearing
Using the Function IndeX for Trauma (FIX-IT) score.0-100; higher scores = better function.
Measured: 2 years
Mobility
Via the Extended Timed Up and Go (TUG) test starting at 3-months.
Measured: 3, 6, 12 and 24 months.
Health-related quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).
via Euro-Qol 5 Dimension (EQ5D). Higher scores = better health-related quality of life.
Measured: 2 years
Health-resource utilization
Using the patient-reported Ambulatory and Home Care Record.
Measured: 2 years
Complications
Including non-union, malunion, infection, implant failure and arthritis.
Measured: 2 years
Re-operations (Type)
Reviewing the type of secondary procedure
Measured: 2 years
Re-operations (Reason)
Reviewing the reason for the secondary procedure
Measured: 2 years
Radiographic
To assess fracture healing and union. Anteroposterior and lateral x-rays of all patients will be obtained at the standard follow-up intervals. The independent adjudication committee will assess fracture healing and union.
Measured: 2 years
Successful initiation of sites
Site fully approved, trained, and ready to begin recruiting participants.
Measured: Through study completion, an average of 24 months.
Data quality
Proportion of CRFs with no missing data/outstanding queries
Measured: Through study completion, an average of 24 months.
Randomization errors/cross-overs
Success: <5%, at least 90% adherence to allocated surgical technique
Measured: Through study completion, an average of 24 months.
The proportion of patients instructed to WBAT in each group
Success: a minimum of 80% of patients are instructed to WBAT postoperative in each group
Measured: Through study completion, an average of 24 months.
Barriers to protocol adherence
qualitative
Measured: Through study completion, an average of 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start1 Sep 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Femur FracturesStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Model description
- A multi-centered, preliminary feasibility RCT across 4 level I trauma centers comparing SIF to DIF for DFFs. Participants are randomized into one of two groups, and each group receives a different intervention (Single Implant Fixation (SIF) or Dual Implant Fixation (DIF)).
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopaedic Trauma Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944964
- Sponsor's protocol ID
- DFF Feasibility Study
- Status last verified
- Sep 2025
- First submitted
- 4 Mar 2025
- Last updated
- 15 Sep 2025
- 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 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single vs. Dual Implant Fixation for Distal Femur Fractures in Older or Compromised Adults
- ClinicalTrials.gov ID
- NCT06944964
- Acronym / sponsor ID
- DFF Feasibility Study
- Conditions
- Distal Femur Fractures
- Keywords
- Single Implant Fixation, Dual Implant Fixation, Dual Plate Fixation, Combination nail-plate fixation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Orthopaedic Trauma Association
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 May 2030 (estimated)
- First posted
- 25 Apr 2025 (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 goal of this clinical trial is to assess the feasibility of conducting a larger study comparing single implant fixation (SIF) and dual implant fixation (DIF) for treating distal femur fractures (DFF) in older or compromised adults. It will also evaluate the safety and effectiveness of these treatments. The main questions it aims to answer are:
- Can DIF improve patient outcomes compared to SIF in older or compromised adults?
- How feasible is it to recruit and retain participants for this trial?
Participants will:
- Be randomly assigned to receive either SIF or DIF for their DFF treatment
- Visit the clinic for follow-ups and assessments of their recovery and bone healing, including potential ultrasound imaging for detecting complications like non-union.
Detailed description
The Investigators aim to conduct a multi-centre, preliminary RCT to determine the feasibility and inform the design of a definitive trial comparing patient-important outcomes between patients aged 40 years and older with distal femur fractures managed with SIF vs. DIF.
Primary Aim: Evaluate the feasibility of conducting a larger, definitive trial examining outcomes following SIF vs. DIF for DFFs in older or compromised adults. Our primary outcomes for this objective will be 1) recruitment and retention at the participating sites; and 2) site investigator feedback regarding barriers to protocol adherence.
Secondary Aims: Pilot the collection of candidate outcome measures to determine the optimal primary end point and sample size for a definitive trial. Our primary outcome for this objective will be the Oxford Knee Score, and secondary outcomes will include a range of patient-reported quality of life (QOL) measures, and objective clinical measures.
In addition, the study includes an ultrasound sub-study aimed at evaluating the feasibility of using ultrasound imaging to monitor bone healing and detect complications like non-union in patients with DFF.
Participants will be randomly assigned to receive either SIF or DIF, with SIF generally involving a single implant (such as a lateral locked plate or retrograde intramedullary nail) and DIF using a combination of implants (e.g., dual plates or a nail and plate). This randomized design will enable us to assess whether dual implant fixation offers improved clinical outcomes, such as reduced morbidity and faster weight-bearing recovery, compared to the more traditional single implant fixation.
Non-Randomized Participation: The investigators will collect data surrounding the number of eligible patients approached for consent, eligible patients not approached for consent and reason why, along with the proportion of patients who do not consent and reasons why to refine our strategy for the definitive trial. For patients who are excluded due to a lack of clinical equipoise, the investigators will provide the option of participating in a concurrent cohort study.This study will record the same variables as the RCT.
The trial will take place at four major trauma centers across Canada: London Health Sciences Centre - Victoria Hospital, St. Michael's Hospital, Sunnybrook Health Sciences Centre, and Alberta Health Services Centre. Participants will receive follow-up visits at these centers, which will include clinical check-ups, rehabilitation sessions, and imaging assessments to track their recovery progress.
The data gathered from this feasibility study will provide critical insights into the practicality of a larger-scale trial and will help inform future treatment strategies for distal femur fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A multi-centered, preliminary feasibility RCT across 4 level I trauma centers comparing SIF to DIF for DFFs. Participants are randomized into one of two groups, and each group receives a different intervention (Single Implant Fixation (SIF) or Dual Implant Fixation (DIF)).
| Arm | Type | Receives |
|---|---|---|
| Group A (Control): Single Implant Fixation (SIF) | Active comparator | Procedure: Single Implant Fixation (SIF)Patients in this arm will undergo fixation of distal femur fractures using a single implant, which could be a lateral locked plate or a retrograde intramedullary nail. |
| Group B (Experimental): Dual Implant Fixation (DIF) | Active comparator | Procedure: Dual Implant Fixation (DIF)Patients in this arm will undergo fixation using dual implants, either dual plate fixation or a combination of nail and plate fixation. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Isolated DFF (native AO/OTA-type A2, A3, C or periprosthetic Lewis and
- Fracture amenable to plating and nailing
- Ability to read and speak English or availability of a translator
- Acute fractures (within 14-days of injury)
- No surgeon preference regarding SIF vs. DIF
Key exclusion criteria (10 listed)
- Candidate for primary or revision arthroplasty (surgeon opinion)
- Periprosthetic fracture with loose implant
- Gustillo grade III open fractures
- Ipsilateral hip implant
- Likely problems, in the judgment of the investigators, with maintaining follow-up (i.e., no fixed address, mentally competent to give consent, etc.)
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 Implant Fixation (SIF)This intervention involves using one implant for fracture fixation. The implant can be either a lateral locked plate or a retrograde intramedullary nail, based on the surgeon's preference. | Procedure or surgery | Group A (Control): Single Implant Fixation (SIF) |
| Dual Implant Fixation (DIF)This intervention involves using two implants for fracture fixation. The combination can be either dual plate fixation (DPF) or combination nail plate fixation (NPF) . | Procedure or surgery | Group B (Experimental): Dual Implant Fixation (DIF) |
Primary outcome
Feasibility Outcomes - Recruitment
Time frame: Through study completion, an average of 1 year.
Recruitment - 1) Recruitment (number of patients enrolled per-month). Success will be considered as each site enrolling a minimum mean of 0.6 patients per-month. This is a conservative estimate based on our previous trials in similar populations, and we expect that each site will screen a minimum of twice this number. * Number of patients enrolled per month * Success if each site able to enroll mean of 0.6 patients per month
Feasibility Outcomes - Retention
Time frame: Through study completion, an average of 1 year.
Retention - (proportion of patients that complete one-year follow-up). Success will be considered a minimum of 85% of patients with complete one-year data. * Proportion of patients that complete 1 year follow up * Success: 85%
Functional Ability
Time frame: 2 year
Via the validated Oxford Knee Score. It ranges from 0 to 48, with higher scores indicating better outcomes (i.e., less pain and better function).
15 secondary outcomes
Pain rating
Time frame: 2 years
Functional ability
Time frame: 2 years
Weight-bearing
Time frame: 2 years
Mobility
Time frame: 3, 6, 12 and 24 months.
Health-related quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).
Time frame: 2 years
Health-resource utilization
Time frame: 2 years
Complications
Time frame: 2 years
Re-operations (Type)
Time frame: 2 years
Re-operations (Reason)
Time frame: 2 years
Radiographic
Time frame: 2 years
Successful initiation of sites
Time frame: Through study completion, an average of 24 months.
Data quality
Time frame: Through study completion, an average of 24 months.
Randomization errors/cross-overs
Time frame: Through study completion, an average of 24 months.
The proportion of patients instructed to WBAT in each group
Time frame: Through study completion, an average of 24 months.
Barriers to protocol adherence
Time frame: Through study completion, an average of 24 months.
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 15 Sep 2025.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Implant Fixation (SIF) and Dual Implant Fixation (DIF) in people with Distal Femur Fractures, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.
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 10 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Contact Emil Schemitsch, MD, FRCS(C) (519-685-8500 ext. 33307, Emil.Schemitsch@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Outcomes - Recruitment (time frame: Through study completion, an average of 1 year.). The study lists 3 primary outcomes in all. 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 15 Sep 2025.