Articular FracturesNCT07237191
Geriatric Distal Femur
A study testing Single Implant Fixation and Dual Implant Fixation in people with Articular Fractures, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare two types of surgical fixation in patients with specific kinds of distal femur fractures. The main questions it aims to answer is which operation for distal femur fractures is better for efficient return to work and everyday activities. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Articular Fractures
- What is being tested?
- Single Implant Fixation and Dual Implant Fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2026to Dec 2029
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 55 years
- Surgically treated displaced distal femur extra articular or complete articular fractures
Who cannot join
- Patients with injury features that preclude treatment with 2 implants
- Patients unlikely to follow-up due to homelessness, or planning follow up at another institution
- Body Mass Index (BMI) > 40
- Injury due to ground level fall
- Patient that speaks neither English or Spanish
- Patients with multisystem injuries that could preclude return to work
- < 55 years of age
- Prisoner
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Atrium Health
Charlotte, North Carolina, 28204
About this study
Official title: Single Impact Versus Dual Implant Fixation of Distal Femur Extra Articular and Complete Articular Fractures in Geriatric Patients
The goal of this clinical trial is to compare two types of surgical fixation in patients with specific kinds of distal femur fractures. The main questions it aims to answer is which operation for distal femur fractures is better for efficient return to work and everyday activities.
Read the detailed description
Fractures of the distal femur are severe and common injuries sustained by older adults. Despite advances in implant technology, these injuries continue to have an unacceptably high rate of nonunion (failure to heal) of approximately 20%. This adverse outcome requires additional surgery to achieve fracture healing, which prolongs recovery and further delays return to activities of daily living and impacts quality of life. Despite numerous studies of a variety of different surgical treatment strategies, the incidence of nonunion remains high. Therefore, any novel strategy to reduce the risk of nonunion and accelerate return to activities after distal femur fracture warrants rigorous study. The goal of this study is to investigate a potential treatment for distal femur fractures that has the potential to improve the likelihood of fracture healing and accelerate return of patient function during the healing process.
- Conditions
- Articular Fractures
- Being tested
- Single Implant Fixation, Dual Implant Fixation
- Keywords
- distal femur fractures, single implant fixation, dual implant 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 FixationProcedure or surgery
Lateral precontoured 4.5 mm distal femur plate or an intramedullary nail at the surgeon's discretion. Standard-of-care techniques will be used by the surgeon for fracture reduction and implant placement.
Dual Implant FixationProcedure or surgery
Lateral precontoured distal femur plate and either (1) an intramedullary nail or (2) a medial plate. The medial plate must span the extra-articular portion of the fracture and must have stiffness of a 3.5 mm reconstruction plate, 3.5 mm limited contact dynamic compression plate, or greater.
| Study group | Role | What they receive |
|---|---|---|
| Single Implant Fixation | Other | Single implant fixation with either a precontoured lateral locking plate or an intramedullary nail which is the current standard of care. Receives: Procedure: Single Implant Fixation |
| Dual Implant Fixation | Other | Dual implant fixation with either a lateral locking plate plus an intramedullary nail or a lateral locking plate plus a supplemental medial plate which is the current standard of care. Receives: Procedure: Dual Implant Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Unions
Union, as determined by the treating surgeon, will be assessed via radiographs and documented as a dichotomous outcome (yes/no), and time to union will also be captured. Nonunion will be captured via surgeon diagnosis or return to the operating room for nonunion treatment.
Measured: 6-week, 3, 6, 12 months
Total Surgical Time - Reoperations
The total surgical time during any reoperations will be collected from the medical record.
Measured: 6-week, 3, 6, 12 months
Number of Reoperations
Details regarding reoperations will also be collected, whether or not the operation results in an inpatient admission.
Measured: 6-week, 3, 6, 12 months
Secondary outcomes (20)
Number of Resource Utilizations
Healthcare utilization, including all hospitalizations, emergency department visits, clinic visits, imaging, and physical therapy sessions after the index stay following injury will be documented at all follow-up visits.
Measured: 6-week, 3, 6, 12 month
Return to Work - International Physical Activity Questionnaire (IPAQ) Scores
Completion of the International Physical Activity Questionnaire (IPAQ). The IPAQ is a validated, self-report measure that captures detailed information about participation in a wide range of physical activities, including the number of days and amount of time spent in the previous 7 days. Responses for each type of physical activity are then transformed into the number of Metabolic Equivalent for Tasks (METs), and a METs/week is calculated for each patient. To get a continuous variable score from the IPAQ (MET minutes a week) it is considered walking to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS. Higher scores meaning more activity.
Measured: Week 6
Return to Work - International Physical Activity Questionnaire (IPAQ) Scores
Completion of the International Physical Activity Questionnaire (IPAQ). The IPAQ is a validated, self-report measure that captures detailed information about participation in a wide range of physical activities, including the number of days and amount of time spent in the previous 7 days. Responses for each type of physical activity are then transformed into the number of Metabolic Equivalent for Tasks (METs), and a METs/week is calculated for each patient. To get a continuous variable score from the IPAQ (MET minutes a week) it is considered walking to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS. Higher scores meaning more activity.
Measured: Month 3
Return to Work - International Physical Activity Questionnaire (IPAQ) Scores
Completion of the International Physical Activity Questionnaire (IPAQ). The IPAQ is a validated, self-report measure that captures detailed information about participation in a wide range of physical activities, including the number of days and amount of time spent in the previous 7 days. Responses for each type of physical activity are then transformed into the number of Metabolic Equivalent for Tasks (METs), and a METs/week is calculated for each patient. To get a continuous variable score from the IPAQ (MET minutes a week) it is considered walking to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS. Higher scores meaning more activity.
Measured: Month 6
Return to Work - International Physical Activity Questionnaire (IPAQ) Scores
Completion of the International Physical Activity Questionnaire (IPAQ). The IPAQ is a validated, self-report measure that captures detailed information about participation in a wide range of physical activities, including the number of days and amount of time spent in the previous 7 days. Responses for each type of physical activity are then transformed into the number of Metabolic Equivalent for Tasks (METs), and a METs/week is calculated for each patient. To get a continuous variable score from the IPAQ (MET minutes a week) it is considered walking to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS. Higher scores meaning more activity.
Measured: Month 12
Time to Walking Without an Assistive Device
Use of an assistive device will be abstracted from the medical record and/or collected via patient interview at each follow up time point.
Measured: 6-week, 3, 6, 12 months
Prescribed Weight Bearing Status
The prescribed weightbearing status will be captured from discharge instructions and clinic notes.
Measured: 6-week, 3, 6, 12 months
Fear of Movement -Tampa Scale for Kinesiophobia (TSK) Scores
Tampa Scale for Kinesiophobia (TSK) will be utilized to measure fear of movement. This scale is 17 items and uses a 4-point Likert scale ranging from 'strongly disagree' to 'strongly agree'. The TSK is a validated measure for surgical and musculoskeletal patients. The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia.
Measured: 6-week, 3, 6, 12 months
Health Related Quality of Life - Patient-Reported Outcomes Measurement Information System (PROMIS) Scores
The PROMIS-29 includes seven domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities. A 5-point Likert scale is used for each question and norm-based total scores (range 0-100) have been calculated so that 50 represents the mean and one standard deviation is 10 points. Higher scores represent better function.
Measured: 6-week, 3, 6, 12 months
Global Health Status - Veterans RAND 12 Item Health Survey (VR12) Scores
The VR-12 is a measure of global health that corresponds to seven domains: general health, physical functioning, role limitations, pain, fatigue, social functioning, and mental health. Scores range from 0 to 100. 0 indicates the lowest level of health and 100 indicates the highest level of health.
Measured: 6-week, 3, 6, 12 months
Work Productivity and Activity Impairment Questionnaire Scores
The Work Productivity and Activity Impairment Questionnaire (WPAI) questionnaire is an instrument to measure impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Measured: 6-week, 3, 6, 12 months
Numeric Pain Rating
Patients will be asked to rate their current pain on a visual analog scale. In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
Measured: 6-week, 3, 6, 12 months
Pain Inventory (BPI)
Pain will be assessed using the Brief Pain Inventory (BPI). The BPI is a commonly used and validated 15-item measure of pain intensity and interference with daily life. The BPI measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. BPI pain interference is typically scored as the mean of the seven interference items. Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain. Higher scores meaning higher pain.
Measured: 6-week, 3, 6, 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Subscale--Pain Interference
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation - scores (range 0-100). Higher scores means a higher level of pain interference.
Measured: 6-week, 3, 6, 12 months
Presence of Post-Traumatic Arthritis (PTOA) - Kellgren Lawrence (KL) Classification
If PTOA is present, Kellgren Lawrence (KL) classification will be assessed by the panel of reviewers and documented. Higher scores represent worse PTOA. Grade 0 - Normal articular cartilage. Grade I - Softening and swelling. Grade II - Fragmentation and fissuring of less than 0.5 inches. Grade III - Fragmentation and fissuring of greater than 0.5 inches. Grade IV - Erosion down to the subchondral bone.
Measured: 1 year
Presence of Post-Traumatic Arthritis (PTOA) - Paley Grading System (PGS)
If PTOA is present, the Paley Grading System (PGS) will be assessed by the panel of reviewers and documented. Higher scores represent worse PTOA. Standard joint space with no evidence of degeneration was set as Grade 0. Normal joint space with the occurrence of osteophytes, subchondral sclerosis, and cysts was set as Grade 1. Joint space narrowing was set as Grade 2. Disappeared joint space was set as Grade 3.
Measured: 1 year
Geriatric Depression Scale
This scale has been validated in many studies and is unique in that it is tailored to a geriatric population by distinguishing between undiagnosed dementia and depression. Patients will also complete this scale to measure depression as part of health-related quality of life. The Geriatric Depression Scale (GDS) includes a total score range of 0 to 15. A score of 5 or more suggests depression. A score of 6 on this scale has a 94% sensitivity and 85% specificity for Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnosed depression.
Measured: 6-week, 3, 6, 12 months
Morphine Milligram Equivalents (MME)
To evaluate pain medication as a confounder to pain scores and complications MME will be calculated at each time point. To assess MME as a confounder, MME will be compared by treatment group at each time point.
Measured: 6-week, 3, 6, 12 months
Total Surgical Time - Index Surgery
The total surgical time during the index surgery will be collected from the medical record
Measured: Baseline
Total Hospital Days
Total hospital days, including the index hospitalization and any subsequent inpatient stays will be captured
Measured: Baseline, 6-week, 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start23 Aug 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Articular FracturesStudies of the same condition, open and under way.
- 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
- Adult patients with extra-articular or complete articular distal femur fractures that will be operatively treated recruited from one of the participating sites during the index hospitalization
- Masking
- None (open label)
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurence Kempton, M.D., Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237191
- Sponsor's protocol ID
- IRB00139405
- Status last verified
- Sep 2026
- First submitted
- 14 Nov 2025
- Last updated
- 30 Sep 2026
- Results posted
- 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Impact Versus Dual Implant Fixation of Distal Femur Extra Articular and Complete Articular Fractures in Geriatric Patients
- ClinicalTrials.gov ID
- NCT07237191
- Acronym / sponsor ID
- IRB00139405
- Conditions
- Articular Fractures
- Keywords
- distal femur fractures, single implant fixation, dual implant fixation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 23 Aug 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 19 Nov 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 compare two types of surgical fixation in patients with specific kinds of distal femur fractures. The main questions it aims to answer is which operation for distal femur fractures is better for efficient return to work and everyday activities.
Detailed description
Fractures of the distal femur are severe and common injuries sustained by older adults. Despite advances in implant technology, these injuries continue to have an unacceptably high rate of nonunion (failure to heal) of approximately 20%. This adverse outcome requires additional surgery to achieve fracture healing, which prolongs recovery and further delays return to activities of daily living and impacts quality of life. Despite numerous studies of a variety of different surgical treatment strategies, the incidence of nonunion remains high. Therefore, any novel strategy to reduce the risk of nonunion and accelerate return to activities after distal femur fracture warrants rigorous study. The goal of this study is to investigate a potential treatment for distal femur fractures that has the potential to improve the likelihood of fracture healing and accelerate return of patient function during the healing process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Adult patients with extra-articular or complete articular distal femur fractures that will be operatively treated recruited from one of the participating sites during the index hospitalization
| Arm | Type | Receives |
|---|---|---|
| Single Implant Fixation | Other | Procedure: Single Implant FixationSingle implant fixation with either a precontoured lateral locking plate or an intramedullary nail which is the current standard of care. |
| Dual Implant Fixation | Other | Procedure: Dual Implant FixationDual implant fixation with either a lateral locking plate plus an intramedullary nail or a lateral locking plate plus a supplemental medial plate which is the current standard of care. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age greater than or equal to 55 years
- Surgically treated displaced distal femur extra articular or complete articular fractures
Key exclusion criteria (8 listed)
- Patients with injury features that preclude treatment with 2 implants
- Patients unlikely to follow-up due to homelessness, or planning follow up at another institution
- Body Mass Index (BMI) > 40
- Injury due to ground level fall
- Patient that speaks neither English or Spanish
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 FixationLateral precontoured 4.5 mm distal femur plate or an intramedullary nail at the surgeon's discretion. Standard-of-care techniques will be used by the surgeon for fracture reduction and implant placement. | Procedure or surgery | Single Implant Fixation |
| Dual Implant FixationLateral precontoured distal femur plate and either (1) an intramedullary nail or (2) a medial plate. The medial plate must span the extra-articular portion of the fracture and must have stiffness of a 3.5 mm reconstruction plate, 3.5 mm limited contact dynamic compression plate, or greater. | Procedure or surgery | Dual Implant Fixation |
Primary outcome
Number of Unions
Time frame: 6-week, 3, 6, 12 months
Union, as determined by the treating surgeon, will be assessed via radiographs and documented as a dichotomous outcome (yes/no), and time to union will also be captured. Nonunion will be captured via surgeon diagnosis or return to the operating room for nonunion treatment.
Total Surgical Time - Reoperations
Time frame: 6-week, 3, 6, 12 months
The total surgical time during any reoperations will be collected from the medical record.
Number of Reoperations
Time frame: 6-week, 3, 6, 12 months
Details regarding reoperations will also be collected, whether or not the operation results in an inpatient admission.
20 secondary outcomes
Number of Resource Utilizations
Time frame: 6-week, 3, 6, 12 month
Return to Work - International Physical Activity Questionnaire (IPAQ) Scores
Time frame: Week 6
Return to Work - International Physical Activity Questionnaire (IPAQ) Scores
Time frame: Month 3
Return to Work - International Physical Activity Questionnaire (IPAQ) Scores
Time frame: Month 6
Return to Work - International Physical Activity Questionnaire (IPAQ) Scores
Time frame: Month 12
Time to Walking Without an Assistive Device
Time frame: 6-week, 3, 6, 12 months
Prescribed Weight Bearing Status
Time frame: 6-week, 3, 6, 12 months
Fear of Movement -Tampa Scale for Kinesiophobia (TSK) Scores
Time frame: 6-week, 3, 6, 12 months
Health Related Quality of Life - Patient-Reported Outcomes Measurement Information System (PROMIS) Scores
Time frame: 6-week, 3, 6, 12 months
Global Health Status - Veterans RAND 12 Item Health Survey (VR12) Scores
Time frame: 6-week, 3, 6, 12 months
Work Productivity and Activity Impairment Questionnaire Scores
Time frame: 6-week, 3, 6, 12 months
Numeric Pain Rating
Time frame: 6-week, 3, 6, 12 months
Pain Inventory (BPI)
Time frame: 6-week, 3, 6, 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Subscale--Pain Interference
Time frame: 6-week, 3, 6, 12 months
Presence of Post-Traumatic Arthritis (PTOA) - Kellgren Lawrence (KL) Classification
Time frame: 1 year
Presence of Post-Traumatic Arthritis (PTOA) - Paley Grading System (PGS)
Time frame: 1 year
Geriatric Depression Scale
Time frame: 6-week, 3, 6, 12 months
Morphine Milligram Equivalents (MME)
Time frame: 6-week, 3, 6, 12 months
Total Surgical Time - Index Surgery
Time frame: Baseline
Total Hospital Days
Time frame: Baseline, 6-week, 3, 6, 12 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 30 Sep 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.
Laurence Kempton, M.D. principal investigator
Wake Forest University Health Sciences
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 Implant Fixation and Dual Implant Fixation in people with Articular Fractures, run by Wake Forest University Health Sciences 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 2 inclusion and 8 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 30 Sep 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?
Contact Laurence Kempton, M.D. (7042553035, laurence.kempton@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Unions (time frame: 6-week, 3, 6, 12 months). 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 30 Sep 2026.