An interventional study of Single Implant Fixation and Dual Implant Fixation in Articular Fractures, sponsored by Wake Forest University Health Sciences. Recruiting at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Single implant fixation with either a precontoured lateral locking plate or an intramedullary nail which is the current standard of care.
Procedure: Single Implant Fixation
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.
Procedure: Dual Implant Fixation
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.
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.
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.
Time frame: 6-week, 3, 6, 12 months
Total Surgical Time - Reoperations
The total surgical time during any reoperations will be collected from the medical record.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6-week, 3, 6, 12 months
Prescribed Weight Bearing Status
The prescribed weightbearing status will be captured from discharge instructions and clinic notes.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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'.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Baseline
Total Hospital Days
Total hospital days, including the index hospitalization and any subsequent inpatient stays will be captured
Time frame: Baseline, 6-week, 3, 6, 12 months
Plan to share: No
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Wake Forest University Health Sciences