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Articular FracturesPRORPNCT06286670

Single Versus Dual Implant Fixation of Distal Femur Fractures

A study testing Single Implant Fixation and Dual Implant Fixation in people with Articular Fractures, run by Wake Forest University Health Sciences at 16 sites 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
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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 18 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
144 participants
Where
16 sitesUnited States
Study dates
16 Sep 2024to Dec 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age greater than or equal to 18 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
  • < 18 years of age
  • Prisoner

Trial locations and contacts

16 sites in 1 country. Contact the study team or a site near you to ask about taking part.

16 sites in 1 country

United States16 sites, 16 recruiting
  • Emory University, Grady Memorial Research Hospital

    Atlanta, Georgia, 30303

    Morgan Fuller, morgan.renae.fuller@emory.edu

    Jason Barron, jason.barron@emory.edu

    Recruiting
  • University of Maryland, Shock Trauma Center

    Baltimore, Maryland, 21201

    Mark Gage, MD

    Casey Loudermilk, CLoudermilk@som.umaryland.edu

    Recruiting
  • University of Alabama Birmingham

    Birmingham, Alabama, 35233

    Clay Spitler, MD, caspitler@uabmc.edu

    Clay Spitler, MD

    Recruiting
  • University of North Carolina Chapel Hill

    Chapel Hill, North Carolina, 27514

    Andrew Chen, MD

    Recruiting
  • Atrium Health Carolinas Medical Center

    Charlotte, North Carolina, 28204

    Christine Churchill, christine.churchill@atriumhealth.org

    Laurence Kempton, MD

    Recruiting
  • Atrium Health Cabarrus

    Concord, North Carolina, 28025

    Erica Grochowski, erica.grochowski@atriumhealth.org

    Luke Harmer, MD

    Recruiting
  • Inova

    Fairfax, Virginia, 22031

    Greg Gaski, MD, greg.gaski@inova.org

    Greg Gaski, MD

    Recruiting
  • University of Texas Medical Branch

    Galveston, Texas, 77555

    Burak Altintas, MD, 409-772-1255, bualtint@UTMB.EDU

    Burak Altintas, MD

    Not yet recruiting
  • Prisma Health- Upstate

    Greenville, South Carolina, 29605

    Kyle Jeray, MD

    Kyle Adams, MS, kyle.adams@prismahealth.org

    Recruiting
  • Pennsylvania State University

    Hershey, Pennsylvania, 17033

    Andrea Myers, amyers1@pennstatehealth.psu.edu

    Jana Davis, MD

    Recruiting
  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Geoffrey Marecek, MD

    Joel Arnold, joel.arnold@cshs.org

    Recruiting
  • Atrium Health Navicent

    Macon, Georgia, 31201

    Adithi Shyam, Adithi.Shyam@Advocatehealth.org

    Jarrod Dumpe, MD

    Recruiting
  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Phillip Mitchell, MD

    Karen Trochez, karen.m.trochez@vumc.org

    Recruiting
  • Louisiana State University

    New Orleans, Louisiana, 70112

    Jessica Rivera, MD

    Jessica Rivera, MD

    Not yet recruiting
  • NYC Health and Hospital/Bellevue

    New York, New York, 10016

    Nina Fisher, MD

    Ivanka Bhambhani, Ivanka.Bhambhani@nyulangone.org

    Not yet recruiting
  • Valley Health

    Winchester, Virginia, 22601

    Ashley Zelaski, 540-536-7542, azelaski2@valleyhealthlink.com

    Kenneth Nelson, MD

    Recruiting

Other trials in United States

About this study

Official title: Single Implant Versus Dual Implant Fixation of Distal Femur Extra Articular and Complete Articular Fractures - PRORP

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 Wounded Warriors in combat. 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 duty often beyond one year after injury. 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 Fracture, Distal Femur complete articular Fracture, Distal Femur extraarticular Fracture
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

    Single implant fixation with either a precontoured lateral locking plate or an intramedullary nail.

  • Dual Implant FixationProcedure or surgery

    Dual implant fixation with either a lateral locking plate plus an intramedullary nail or a lateral locking plate plus a supplemental medial plate.

Study groups in NCT06286670
Study groupRoleWhat they receive
Single Implant FixationOtherSingle implant fixation with either a precontoured lateral locking plate or an intramedullary nail.
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.
Receives: Procedure: Dual Implant Fixation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  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: Month 3

  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

  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 12

Secondary outcomes (19)
  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. 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

  3. Number of Reoperations

    Details regarding reoperations will also be collected, whether or not the operation results in an inpatient admission. The total surgical time during any reoperations will be collected from the medical record.

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

  4. Number of Complications

    Major complications, including infection, nonunion, malunion, and hardware failure will be captured from the medical record.

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

  5. 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

  6. Prescribed Weight Bearing Status

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

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

  7. Fear of Movement - Change in 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

  8. Health Related Quality of Life - Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Scores

    The National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) project was initiated to improve the precision of self assessment instruments, reduce respondent burden and enhance the comparability of health outcomes measures. 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. Additionally, higher scores represent better function.

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

  9. Global Health Status - Change in Veterans RAND 12 Item Health Survey (VR12) Scores

    Patients will complete the Veterans RAND 12 Item Health Survey (VR12).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, where a zero score indicates the lowest level of health and 100 indicates the highest level of health.

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

  10. Change in the Work Productivity and Activity Impairment Questionnaire Scores

    Patients will complete 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.

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

  11. Change in 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

  12. Change in 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

  13. Change in 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

  14. 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

  15. 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

  16. Isokinetic Knee Flexion/Extension Strength Testing

    Knee flexion and extension strength testing will be performed on an isokinetic dynamometer (Biodex Medical Systems, Shirley, NY) with the participant in a seated position with the torso straps and thigh strap (for the tested lower extremity) in place in order to reduce accessory motion and isolate knee flexion and extension performance. The reliability of the knee protocol has been previously established and has been demonstrated to be excellent. The knee strength testing protocol is a concentric-concentric reciprocal protocol with five complete repetitions at 60º/s. Each participant will perform three practice repetitions at 50% maximum effort and three practice repetitions at 100% effort prior to testing for data analysis. Testing will be performed bilaterally for all participants. Average peak moment (averaged across the five repetitions) normalized to percent body weight will be calculated for each (knee flexion/extension).

    Measured: Up to Year 1

  17. Counter-Movement Jump measurement

    Patients will be asked to perform a double-leg and single-leg countermovement jump to assess jump height, concentric force development (take-off), and force dissipation (landing) (VALD Force Deck System). Patients will be asked to perform three repetitions of countermovement jump for maximal height off of a force plate followed by landing on the same force plate.

    Measured: Up to Year 1

  18. Single Leg Static and Dynamic Postural Stability Index

    The average of three 10-second trials will be collected for data analysis for eyes closed and eyes open. The variable to be analyzed will the standard deviation of resultant ground reaction force across the 10-second trial. Dynamic postural stability will be assessed during a single-leg landing. Patients will be asked to jump forward to the force plate, clear a 30.5 cm hurdle, land on the force plate with their test leg only, stabilize as quickly as possible, and maintain balance with their hands on their hips for ten seconds. A total of three trials will be collected and averaged together for analysis. A stability index based on the three ground reaction force components will be calculated as described previously.

    Measured: Up to Year 1

  19. Triple Hop Performance Assessment

    Bilateral assessment of jump performance will be performed during a triple hop (cross-over) for maximum distance. Participants will be provided with a practice trial at 50 percent maximum effort prior to the test trials and testing will begin with non-surgical left first. Participants will begin the jump behind zero-inch line, which marks the starting point. Participants will perform three consecutive jumps off one leg while crossing over the tape with each jump so that the first jump is lateral, the second jump is medial, and the final jump is lateral. Participants will be asked to hold their place at the end of the third jump until their distance is recorded. Three test trials will be assessed for each leg and averaged together for analysis.

    Measured: Up to Year 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Feb 2024
  2. Study start16 Sep 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (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
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06286670
Sponsor's protocol ID
IRB00108312
Other IDs
HT94252311075
Acronym
PRORP
Status last verified
Feb 2026
First submitted
9 Feb 2024
Last updated
7 Apr 2026
Results posted
No
Data monitoring committee
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 16 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 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 7 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 16 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?

Contact Rachel Seymour, PhD (704.355.2000, Rachel.Seymour@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Return to Work - International Physical Activity Questionnaire (IPAQ) Scores (time frame: Week 6). 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?
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 7 Apr 2026.

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