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Allograft vs. Autograft for Nonunion Fracture

This study is looking at whether patients who have a nonunion fracture (a broken bone that hasn't healed properly) return to their normal activities faster with one of two surgical procedures: autograft or allograft. An autograft uses your own bone, usually from your hip or another long bone, to help the fracture heal. An allograft uses bone from a deceased donor. The study wants to see if patients receiving an allograft return to work sooner than those receiving an autograft. You may be able to join if you are 18 or older, have a nonunion in a long bone (like your arm or leg), and your surgery will be at least five months after your initial fracture repair. The study will measure how quickly you can return to your usual activities.

Study design
This is a randomized controlled trial, meaning participants will be randomly assigned to one of two treatment groups. The study plans to enroll 156 participants.
What's involved
Participants will complete follow-up surveys during their recovery.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be checked at Week 6, Month 3, and Month 6 after your treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07310082

Allograft vs. Autograft Nonunion

Not Yet Recruiting
NAAges 18+InterventionalTreatment
Wake Forest University Health Sciences
~156 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:AutograftAllograft

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Metabolic Equivalent for Tasks Score
Measured over Week 6
+11 more outcomes measured

Conditions

Nonunion Fracture

Explore related trials

Fracture, ununited

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Joseph R Hsu, MD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences

Who to contact

Christine Churchill
[email protected]
704-355-6947
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Metabolic Equivalent for Tasks ScoreWeek 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 ScoreMonth 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 ScoreMonth 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 ScoreMonth 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/DutyWeek 6

    Average number of days it takes for participants to return to work/duty

  • Average Time to Return to Work/DutyMonth 3

    Average number of days it takes for participants to return to work/duty

  • Average Time to Return to Work/DutyMonth 6

    Average number of days it takes for participants to return to work/duty

  • Average Time to Return to Work/DutyMonth 12

    Average number of days it takes for participants to return to work/duty

  • Number of Participants Returned to WorkWeek 6

    Determined by asking whether subjects have returned to work

  • Number of Participants Returned to WorkMonth 3

    Determined by asking whether subjects have returned to work

  • Number of Participants Returned to WorkMonth 6

    Determined by asking whether subjects have returned to work

  • Number of Participants Returned to WorkMonth 12

    Determined by asking whether subjects have returned to work