Nonunion FractureNCT07310082
Allograft vs. Autograft Nonunion
A study testing Autograft and Allograft in people with Nonunion Fracture, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonunion Fracture
- What is being tested?
- Autograft and Allograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Prisoner
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, 28203
Rachel B Seymour, PhD, 704-441-5365, Rachel.Seymour@advocatehealth.org
Christine Churchill, MA, Christine.Churchill@advocatehealth.org
About this study
Official title: Allograft vs. Autograft to Improve Timely Return to Duty Following Nonunion
The purpose of this research study is to find out if patients treated for nonunion fracture with autograft or allograft return to activity faster.
Read the 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.
- Conditions
- Nonunion Fracture
- Being tested
- Autograft, Allograft
- Keywords
- Allograft, Autograft, Nonunion
- Medical subject headings
- Fractures, Ununited
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AutograftProcedure or surgery
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.
AllograftProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Autograft | Active comparator | Patients randomized to autograft Receives: Procedure: Autograft |
| Allograft | Active comparator | Patients randomized to allograft. Receives: Procedure: Allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 12
Average Time to Return to Work/Duty
Average number of days it takes for participants to return to work/duty
Measured: Week 6
Average Time to Return to Work/Duty
Average number of days it takes for participants to return to work/duty
Measured: Month 3
Average Time to Return to Work/Duty
Average number of days it takes for participants to return to work/duty
Measured: Month 6
Average Time to Return to Work/Duty
Average number of days it takes for participants to return to work/duty
Measured: Month 12
Number of Participants Returned to Work
Determined by asking whether subjects have returned to work
Measured: Week 6
Number of Participants Returned to Work
Determined by asking whether subjects have returned to work
Measured: Month 3
Number of Participants Returned to Work
Determined by asking whether subjects have returned to work
Measured: Month 6
Number of Participants Returned to Work
Determined by asking whether subjects have returned to work
Measured: Month 12
Secondary outcomes (16)
Percentage of Union
Percentage of union will be assessed via radiographs and determined by the treating surgeon.
Measured: Week 6, Month 3, Month 6, Month 12
Time to Union
Number of days to union
Measured: 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.
Measured: Month 12
Number of Participants who Return to the Operating Room
Number of participants who return to the Operating Room after procedure
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 6, Month 3, Month 6, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study startJan 2027 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonunion FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph R Hsu, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310082
- Sponsor's protocol ID
- IRB00140521
- Other IDs
- HT9425-25-1-0424
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allograft vs. Autograft to Improve Timely Return to Duty Following Nonunion
- ClinicalTrials.gov ID
- NCT07310082
- Acronym / sponsor ID
- IRB00140521
- Conditions
- Nonunion Fracture
- Keywords
- Allograft, Autograft, Nonunion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autograft | Active comparator | Procedure: AutograftPatients randomized to autograft |
| Allograft | Active comparator | Procedure: AllograftPatients randomized to allograft. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AutograftSurgeons 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. | Procedure or surgery | Autograft |
| AllograftAllograft 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. | Procedure or surgery | Allograft |
Primary outcome
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.
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: 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
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: 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
Number of Participants Returned to Work
Time frame: Month 12
Determined by asking whether subjects have returned to work
16 secondary outcomes
Percentage of Union
Time frame: Week 6, Month 3, Month 6, Month 12
Time to Union
Time frame: Week 6, Month 3, Month 6, Month 12
Radiographic Union Scale in Tibial fractures (RUST) score
Time frame: Month 12
Number of Participants who Return to the Operating Room
Time frame: Week 6, Month 3, Month 6, Month 12
PROMIS-29 Subscale - Physical Function
Time frame: Week 6, Month 3, Month 6, Month 12
PROMIS-29 Subscale - Anxiety
Time frame: Week 6, Month 3, Month 6, Month 12
PROMIS-29 Subscale - Depression
Time frame: Week 6, Month 3, Month 6, Month 12
PROMIS-29 Subscale - Fatigue
Time frame: Week 6, Month 3, Month 6, Month 12
PROMIS-29 Subscale - Sleep Disturbance
Time frame: Week 6, Month 3, Month 6, Month 12
PROMIS-29 Subscale - Pain Interference
Time frame: Week 6, Month 3, Month 6, Month 12
PROMIS-29 Subscale - Ability to Participate in Social Roles and Activities
Time frame: Week 6, Month 3, Month 6, Month 12
Number of Resource Utilizations
Time frame: Week 6, Month 3, Month 6, Month 12
Pain Intensity Scores
Time frame: Week 6, Month 3, Month 6, Month 12
Veterans RAND 12 Item Health Survey (VR-12) Scores
Time frame: Week 6, Month 3, Month 6, Month 12
Work Productivity and Activity Impairment Questionnaire Scores
Time frame: Week 6, Month 3, Month 6, Month 12
Number of Complications
Time frame: Week 6, Month 3, Month 6, Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph R Hsu, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autograft and Allograft in people with Nonunion Fracture, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine Churchill (704-355-6947, Christine.Churchill@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic Equivalent for Tasks Score (time frame: Week 6). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.