AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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.

Laurence Kempton, M.D. contact

7042553035

laurence.kempton@advocatehealth.org

United States1 site, 1 recruiting
  • Atrium Health

    Charlotte, North Carolina, 28204

    Recruiting

Other trials in United States

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.

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 groups in NCT07237191
Study groupRoleWhat they receive
Single Implant FixationOtherSingle 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 FixationOtherDual 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.

  1. 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

  2. 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

  3. 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)
  1. 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

  2. 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

  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 3

  4. 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

  5. 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

  6. 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

  7. Prescribed Weight Bearing Status

    The prescribed weightbearing status will be captured from discharge instructions and clinic notes.

    Measured: 6-week, 3, 6, 12 months

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. Total Surgical Time - Index Surgery

    The total surgical time during the index surgery will be collected from the medical record

    Measured: Baseline

  20. 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.

  1. First posted19 Nov 2025
  2. Study start23 Aug 2026
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

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)
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

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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in