Allograft vs. Autograft Nonunion

Wake Forest University (WFU)

Status: Begins enrollment this month

Conditions: Nonunion Fracture

Treatments: Procedure: Allograft; Procedure: Autograft

Study type: Interventional

Funder types: Other

Identifiers

NCT07310082

IRB00140521

HT9425-25-1-0424 (Other Grant/Funding Number)

Details and patient eligibility

About

The purpose of this research study is to find out if patients treated for nonunion fracture with autograft or allograft return to activity faster.

Full 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.

Enrollment: 156 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

156 participants in 2 patient groups

Autograft

Active Comparator group

Description:

Patients randomized to autograft

Treatment:

Procedure: Autograft

Allograft

Active Comparator group

Description:

Patients randomized to allograft.

Treatment:

Procedure: Allograft