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.
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
- 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
- Not yet recruiting
University of Texas Medical Branch
Galveston, Texas, 77555
Burak Altintas, MD, 409-772-1255, bualtint@UTMB.EDU
Burak Altintas, MD
- 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
- Not yet 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
- Recruiting
Valley Health
Winchester, Virginia, 22601
Ashley Zelaski, 540-536-7542, azelaski2@valleyhealthlink.com
Kenneth Nelson, MD
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.
- Conditions
- Articular Fractures
- 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 group | Role | What they receive |
|---|---|---|
| Single Implant Fixation | Other | Single implant fixation with either a precontoured lateral locking plate or an intramedullary nail. 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. Receives: Procedure: Dual Implant Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (19)
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
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
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
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
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 - 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
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
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
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
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
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
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
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
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
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
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
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.
- First posted29 Feb 2024
- Study start16 Sep 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (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.
- More trials run by Wake Forest University Health SciencesThe 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
- 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)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Laurence Kempton, MD, Principal investigator, Wake Forest University Health Sciences
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Implant Versus Dual Implant Fixation of Distal Femur Extra Articular and Complete Articular Fractures - PRORP
- ClinicalTrials.gov ID
- NCT06286670
- Acronym / sponsor ID
- PRORP / IRB00108312
- Conditions
- Articular Fractures
- Keywords
- Distal Femur Fracture, Distal Femur complete articular Fracture, Distal Femur extraarticular Fracture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Feb 2024 (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 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.
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. |
| 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. |
Who may qualify
- Ages
- 18 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 18 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 FixationSingle implant fixation with either a precontoured lateral locking plate or an intramedullary nail. | Procedure or surgery | Single Implant Fixation |
| 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. | Procedure or surgery | Dual Implant Fixation |
Primary outcome
Return to Work - International Physical Activity Questionnaire (IPAQ) Scores
Time frame: Week 6
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.
Return to Work - International Physical Activity Questionnaire (IPAQ) Scores
Time frame: Month 3
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.
Return to Work - International Physical Activity Questionnaire (IPAQ) Scores
Time frame: Month 6
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.
Return to Work - International Physical Activity Questionnaire (IPAQ) Scores
Time frame: Month 12
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.
19 secondary outcomes
Number of Unions
Time frame: 6-week, 3, 6, 12 months
Number of Resource Utilizations
Time frame: 6-week, 3, 6, 12 month
Number of Reoperations
Time frame: 6-week, 3, 6, 12 months
Number of Complications
Time frame: 6-week, 3, 6, 12 months
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 - Change in Tampa Scale for Kinesiophobia (TSK) Scores
Time frame: 6-week, 3, 6, 12 months
Health Related Quality of Life - Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Scores
Time frame: 6-week, 3, 6, 12 months
Global Health Status - Change in Veterans RAND 12 Item Health Survey (VR12) Scores
Time frame: 6-week, 3, 6, 12 months
Change in the Work Productivity and Activity Impairment Questionnaire Scores
Time frame: 6-week, 3, 6, 12 months
Change in Numeric Pain Rating
Time frame: 6-week, 3, 6, 12 months
Change in Pain Inventory (BPI)
Time frame: 6-week, 3, 6, 12 months
Change in 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
Isokinetic Knee Flexion/Extension Strength Testing
Time frame: Up to Year 1
Counter-Movement Jump measurement
Time frame: Up to Year 1
Single Leg Static and Dynamic Postural Stability Index
Time frame: Up to Year 1
Triple Hop Performance Assessment
Time frame: Up to Year 1
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 7 Apr 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, MD principal investigator
Wake Forest University Health Sciences
16 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 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.