NCT07310082

Allograft vs. Autograft Nonunion

Allograft vs. Autograft to Improve Timely Return to Duty Following Nonunion

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
PROCEDURE	Autograft	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.
PROCEDURE	Allograft	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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2030-12-01
• Completion: 2030-12-01
• First posted: 2025-12-30
• Last updated: 2026-04-08

Locations

1 site across 1 country: United States