Allograft vs. Autograft Nonunion

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.

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.

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