Allograft vs. Autograft to Improve Timely Return to Duty Following Nonunion
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 156
- Locations
- 2
- Primary Endpoint
- Metabolic Equivalent for Tasks Score
Study Overview
Brief Summary
The purpose of this research study is to find out if patients treated for nonunion fracture with autograft or allograft return to activity faster.
Detailed Description
The goal of this multi-center prospective randomized controlled trial is to compare short and long-term outcomes of adult patients with long-bone nonunion treated with autograft versus allograft. The main question it aims to answer is: will patients who receive an allograft return to work faster than patients who receive an autograft to treat nonunion fracture.
Participants will be randomized to one of two treatment groups and will complete follow-up surveys during their recovery.
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
- •Patients 18 years or older
- •Long bone (tibia, femur, and humerus) nonunion appropriate for either study treatment: to be treated with bone graft harvested from a remote site or using reamer harvester (RIA)
- •Nonunion surgery to be performed at least five months after initial fracture fixation
- •Prior operative fixation of fracture
- •Radiographic apparent bone gap (RABG) of >5cm
Exclusion Criteria
- •Patient that speaks neither English nor Spanish
- •Patients whose treatment plan includes local autograft only (available callus from the nonunion site or no planned bone graft)
- •Known active infection (defined as any clinical signs or symptoms of active infection, such as fevers, wound redness, warmth, swelling, induration or drainage, and abnormal while blood cell count, erythrocyte sedimentation rate, or C-reactive protein) being treated with antibiotics
- •Body mass index greater than 50
- •Patients unlikely to follow-up due to homelessness, or planning follow-up at another institution
Arms & Interventions
Allograft
Patients randomized to allograft.
Intervention: Allograft (Procedure)
Autograft
Patients randomized to autograft
Intervention: Autograft (Procedure)
Outcomes
Primary Outcomes
Metabolic Equivalent for Tasks Score
Time Frame: Week 6
Time to return to work/duty will be measured using the 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.
Metabolic Equivalent for Tasks Score
Time Frame: Month 3
Time to return to work/duty will be measured using the 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.
Metabolic Equivalent for Tasks Score
Time Frame: Month 6
Time to return to work/duty will be measured using the 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.
Average Time to Return to Work/Duty
Time Frame: Week 6
Average number of days it takes for participants to return to work/duty
Average Time to Return to Work/Duty
Time Frame: Month 3
Average number of days it takes for participants to return to work/duty
Average Time to Return to Work/Duty
Time Frame: Month 6
Average number of days it takes for participants to return to work/duty
Number of Participants Returned to Work
Time Frame: Week 6
Determined by asking whether subjects have returned to work
Number of Participants Returned to Work
Time Frame: Month 3
Determined by asking whether subjects have returned to work
Number of Participants Returned to Work
Time Frame: Month 6
Determined by asking whether subjects have returned to work
Metabolic Equivalent for Tasks Score
Time Frame: Month 12
Time to return to work/duty will be measured using the 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.
Metabolic Equivalent for Tasks Score
Time Frame: Month 12
Time to return to work/duty will be measured using the 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.
Average Time to Return to Work/Duty
Time Frame: Month 12
Average number of days it takes for participants to return to work/duty
Number of Participants Returned to Work
Time Frame: Month 12
Determined by asking whether subjects have returned to work
Secondary Outcomes
- Radiographic Union Scale in Tibial fractures (RUST) score(Month 12)
- Number of Participants who Return to the Operating Room(Week 6, Month 3, Month 6, Month 12)
- PROMIS-29 Subscale - Physical Function(Week 6, Month 3, Month 6, Month 12)
- PROMIS-29 Subscale - Anxiety(Week 6, Month 3, Month 6, Month 12)
- PROMIS-29 Subscale - Depression(Week 6, Month 3, Month 6, Month 12)
- PROMIS-29 Subscale - Fatigue(Week 6, Month 3, Month 6, Month 12)
- PROMIS-29 Subscale - Sleep Disturbance(Week 6, Month 3, Month 6, Month 12)
- PROMIS-29 Subscale - Ability to Participate in Social Roles and Activities(Week 6, Month 3, Month 6, Month 12)
- Number of Resource Utilizations(Week 6, Month 3, Month 6, Month 12)
- Pain Intensity Scores(Week 6, Month 3, Month 6, Month 12)
- Veterans RAND 12 Item Health Survey (VR-12) Scores(Week 6, Month 3, Month 6, Month 12)
- Work Productivity and Activity Impairment Questionnaire Scores(Week 6, Month 3, Month 6, Month 12)
- Number of Complications(Week 6, Month 3, Month 6, Month 12)
- Time to Union(Week 6, Month 3, Month 6, Month 12)
- PROMIS-29 Subscale - Ability to Participate in Social Roles and Activities(Week 6, Month 3, Month 6, Month 12)
- Number of Resource Utilizations(Week 6, Month 3, Month 6, Month 12)
- Pain Intensity Scores(Week 6, Month 3, Month 6, Month 12)
- Veterans RAND 12 Item Health Survey (VR-12) Scores(Week 6, Month 3, Month 6, Month 12)
- Work Productivity and Activity Impairment Questionnaire Scores(Week 6, Month 3, Month 6, Month 12)
- Percentage of Union(Week 6, Month 3, Month 6, Month 12)
- Radiographic Union Scale in Tibial fractures (RUST) score(Month 12)
- Number of Participants who Return to the Operating Room(Week 6, Month 3, Month 6, Month 12)
- PROMIS-29 Subscale - Pain Interference(Week 6, Month 3, Month 6, Month 12)
- PROMIS-29 Subscale - Physical Function(Week 6, Month 3, Month 6, Month 12)
- PROMIS-29 Subscale - Anxiety(Week 6, Month 3, Month 6, Month 12)
- PROMIS-29 Subscale - Depression(Week 6, Month 3, Month 6, Month 12)
- PROMIS-29 Subscale - Fatigue(Week 6, Month 3, Month 6, Month 12)
- PROMIS-29 Subscale - Sleep Disturbance(Week 6, Month 3, Month 6, Month 12)
- Number of Complications(Week 6, Month 3, Month 6, Month 12)