An interventional study of Autograft and Allograft in Nonunion Fracture, sponsored by Wake Forest University Health Sciences. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
The purpose of this research study is to find out if patients treated for nonunion fracture with autograft or allograft return to activity faster.
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.
43 studies on the registry are indexed under Fractures, Ununited; 10 are open to participants now.
This study's planned enrollment of 156 is above the median of 60 across 27 interventional studies indexed under Fractures, Ununited.
Browse Fractures, Ununited studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients randomized to autograft
Procedure: Autograft
Patients randomized to allograft.
Procedure: Allograft
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.
Metabolic Equivalent for Tasks Score
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
Metabolic Equivalent for Tasks Score
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
Metabolic Equivalent for Tasks Score
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
Metabolic Equivalent for Tasks Score
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
Average Time to Return to Work/Duty
Average number of days it takes for participants to return to work/duty
Time frame: Week 6
Average Time to Return to Work/Duty
Average number of days it takes for participants to return to work/duty
Time frame: Month 3
Average Time to Return to Work/Duty
Average number of days it takes for participants to return to work/duty
Time frame: Month 6
Average Time to Return to Work/Duty
Average number of days it takes for participants to return to work/duty
Time frame: Month 12
Number of Participants Returned to Work
Determined by asking whether subjects have returned to work
Time frame: Week 6
Number of Participants Returned to Work
Determined by asking whether subjects have returned to work
Time frame: Month 3
Number of Participants Returned to Work
Determined by asking whether subjects have returned to work
Time frame: Month 6
Number of Participants Returned to Work
Determined by asking whether subjects have returned to work
Time frame: Month 12
Percentage of Union
Percentage of union will be assessed via radiographs and determined by the treating surgeon.
Time frame: Week 6, Month 3, Month 6, Month 12
Time to Union
Number of days to union
Time frame: Week 6, Month 3, Month 6, Month 12
Radiographic Union Scale in Tibial fractures (RUST) score
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: Month 12
Number of Participants who Return to the Operating Room
Number of participants who return to the Operating Room after procedure
Time frame: Week 6, Month 3, Month 6, Month 12
PROMIS-29 Subscale - Physical Function
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
PROMIS-29 Subscale - Anxiety
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
PROMIS-29 Subscale - Depression
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
PROMIS-29 Subscale - Fatigue
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
PROMIS-29 Subscale - Sleep Disturbance
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
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. Higher scores means a higher level of pain interference.
Time frame: Week 6, Month 3, Month 6, Month 12
PROMIS-29 Subscale - Ability to Participate in Social Roles and Activities
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
Number of Resource Utilizations
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 Intensity Scores
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
Veterans RAND 12 Item Health Survey (VR-12) Scores
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
Work Productivity and Activity Impairment Questionnaire Scores
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 Complications
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.
Time frame: Week 6, Month 3, Month 6, Month 12
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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