Not Yet RecruitingNot Applicable

Allograft vs. Autograft Nonunion

United States156 participantsStarted 2026-07

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * Prisoner

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Metabolic Equivalent for Tasks Score

Timeframe: Week 6

Metabolic Equivalent for Tasks Score

Timeframe: Month 3

Metabolic Equivalent for Tasks Score

Timeframe: Month 6

Metabolic Equivalent for Tasks Score

Timeframe: Month 12

Average Time to Return to Work/Duty

Timeframe: Week 6

Average Time to Return to Work/Duty

Timeframe: Month 3

Average Time to Return to Work/Duty

Timeframe: Month 6

Average Time to Return to Work/Duty

Timeframe: Month 12

Trial details

NCT IDNCT07310082

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-12

Contact for this trial

Christine Churchill

704-355-6947 Christine.Churchill@advocatehealth.org

View on ClinicalTrials.gov More Nonunion Fracture trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Metabolic Equivalent for Tasks Score

Timeframe: Week 6

Metabolic Equivalent for Tasks Score

Timeframe: Month 3

Metabolic Equivalent for Tasks Score

Timeframe: Month 6

Metabolic Equivalent for Tasks Score

Timeframe: Month 12

Average Time to Return to Work/Duty

Timeframe: Week 6

Average Time to Return to Work/Duty

Timeframe: Month 3

Average Time to Return to Work/Duty

Timeframe: Month 6

Average Time to Return to Work/Duty

Timeframe: Month 12