Single Implant Versus Dual Implant Fixation of Distal Femur Extra Articular and Complete Articular Fractures - PRORP
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 144
- Locations
- 23
- Primary Endpoint
- Return to Work - International Physical Activity Questionnaire (IPAQ) Scores
Study Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age greater than or equal to 18 years
- •Surgically treated displaced distal femur extra articular or complete articular fractures
Exclusion Criteria
- •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
Arms & Interventions
Single Implant Fixation
Single implant fixation with either a precontoured lateral locking plate or an intramedullary nail.
Intervention: Single Implant Fixation (Procedure)
Dual 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.
Intervention: Dual Implant Fixation (Procedure)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Number of Resource Utilizations(6-week, 3, 6, 12 month)
- Time to Walking Without an Assistive Device(6-week, 3, 6, 12 months)
- Prescribed Weight Bearing Status(6-week, 3, 6, 12 months)
- Change in Pain Inventory (BPI)(6-week, 3, 6, 12 months)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Subscale--Pain Interference(6-week, 3, 6, 12 months)
- Number of Reoperations(6-week, 3, 6, 12 months)
- Number of Complications(6-week, 3, 6, 12 months)
- Triple Hop Performance Assessment(Up to Year 1)
- Number of Unions(6-week, 3, 6, 12 months)
- Fear of Movement - Change in Tampa Scale for Kinesiophobia (TSK) Scores(6-week, 3, 6, 12 months)
- Health Related Quality of Life - Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Scores(6-week, 3, 6, 12 months)
- Global Health Status - Change in Veterans RAND 12 Item Health Survey (VR12) Scores(6-week, 3, 6, 12 months)
- Change in the Work Productivity and Activity Impairment Questionnaire Scores(6-week, 3, 6, 12 months)
- Change in Numeric Pain Rating(6-week, 3, 6, 12 months)
- Presence of Post-Traumatic Arthritis (PTOA) - Paley Grading System (PGS(1 year)
- Presence of Post-Traumatic Arthritis (PTOA) - Kellgren Lawrence (KL) classification(1 year)
- Isokinetic Knee Flexion/Extension Strength Testing(Up to Year 1)
- Counter-Movement Jump measurement(Up to Year 1)
- Single Leg Static and Dynamic Postural Stability Index(Up to Year 1)