NCT Number: NCT07310082
The purpose of this research study is to find out if patients treated for nonunion fracture with autograft or allograft return to activity faster.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Charlotte, North Carolina, 28203, United States
Christine Churchill, MA
CONTACT
Garrett Bullock, MD
SUB_INVESTIGATOR
Kevin Phelps, MD
SUB_INVESTIGATOR
Laurence Kempton, MD
SUB_INVESTIGATOR
Madhav Karunakar, MD
SUB_INVESTIGATOR
Meghan Wally, PhD
SUB_INVESTIGATOR
Rachel B Seymour, PhD
CONTACT
Rachel B Seymour, PhD
SUB_INVESTIGATOR
Sarah Pierrie, MD
SUB_INVESTIGATOR
Sophia Traven, MD
SUB_INVESTIGATOR
Suman Medda, MD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Surgeons will decide on the location and method of donor site based on the clinical situation. Most commonly, bone graft will be harvested from the anterior or posterior iliac crest or utilizing the Reamer Irrigator Aspirator in an appropriate long bone. Surgeons may choose to harvest autograft from proximal tibia or distal femur. Donor site location is at the discretion of treating surgeon for patients who randomize to autograft. This treatment arm will not include local autograft only. For large bone defects requiring expansion of autograft with allograft, this will be allowed and recorded. We will use intent-to-treat for statistical analysis of those with allograft expansion of autograft. This autograft will be applied to the nonunion site using the surgeon's typical technique. Internal fixation, revision of fixation, and/or augmentation of fixation will be performed at the discretion of the surgeon.
Allograft bone will consist of cancellous or corticocancellous sterile packaged human cadaveric bone. No bone morphogenetic protein, bone marrow aspirate, or other biologic augment will be added. Demineralized bone matrix may be added at the surgeon's discretion. This allograft will be applied to the nonunion site using the surgeon's typical technique. Internal fixation, revision of fixation, and/or augmentation of fixation will be performed at the discretion of the surgeon.
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.
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.
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.
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.
Time frame: Week 6
Average number of days it takes for participants to return to work/duty
Time frame: Month 3
Average number of days it takes for participants to return to work/duty
Time frame: Month 6
Average number of days it takes for participants to return to work/duty
Time frame: Month 12
Average number of days it takes for participants to return to work/duty
Time frame: Week 6
Determined by asking whether subjects have returned to work
Time frame: Month 3
Determined by asking whether subjects have returned to work
Time frame: Month 6
Determined by asking whether subjects have returned to work
Time frame: Month 12
Determined by asking whether subjects have returned to work
Time frame: Week 6, Month 3, Month 6, Month 12
Percentage of union will be assessed via radiographs and determined by the treating surgeon.
Time frame: Week 6, Month 3, Month 6, Month 12
Number of days to union
Time frame: Month 12
The RUST score ranges from a minimum score of 4 (definitely not healed) to a maximum score of 12 (completely healed). The final x-ray obtained within a 12-month period following injury will be uploaded to REDCap for review by a blinded panel of investigators from participating sites.
Time frame: Week 6, Month 3, Month 6, Month 12
Number of participants who return to the Operating Room after procedure
Time frame: Week 6, Month 3, Month 6, Month 12
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. Higher scores means higher physical function.
Time frame: Week 6, Month 3, Month 6, Month 12
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. Higher scores means a higher level of anxiety.
Time frame: Week 6, Month 3, Month 6, Month 12
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. Higher scores means a higher level of depression
Time frame: Week 6, Month 3, Month 6, Month 12
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. Higher scores means a higher level of fatigue.
Time frame: Week 6, Month 3, Month 6, Month 12
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. Higher scores means a higher level of sleep disturbance.
Time frame: Week 6, Month 3, Month 6, Month 12
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. Higher scores means a higher level of pain interference.
Time frame: Week 6, Month 3, Month 6, Month 12
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. Higher scores means a higher ability to participate in social roles and activities.
Time frame: Week 6, Month 3, Month 6, Month 12
Healthcare utilization, including new hospitalizations, emergency department visits, clinic visits, imaging, and physical therapy sessions will be documented at all follow-up visits
Time frame: Week 6, Month 3, Month 6, Month 12
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. Worst pain score 1-4 = mild pain, 5-6 = moderate pain, 7-10 = severe pain.
Time frame: Week 6, Month 3, Month 6, Month 12
The VR-12 is a measure of global health that correspond to seven domains: general health, physical functioning, role limitations, pain, fatigue, social functioning, and mental health. Together, these items are summarized into a Physical Component Score and a Mental Component Score. Scores range from 0-100 with higher scores indicating better physical and mental health functioning.
Time frame: Week 6, Month 3, Month 6, Month 12
Participants who report return to work/duty will complete the Work Productivity and Activity Impairment Questionnaire, a validated instrument that measures work time missed and work and activity impairment due to health problems. Measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. The higher number of day equates to more health problems.
Time frame: Week 6, Month 3, Month 6, Month 12
Number of major complications, including infection, implant failure, unplanned or planned return to the operating room related to the nonunion procedure, deep venous thrombosis, or pulmonary embolism.
Contact information is provided by the study sponsor or research team.
Wake Forest University Health Sciences
Other
Allograft vs. Autograft to Improve Timely Return to Duty Following Nonunion
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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