Allograft vs. Autograft Nonunion

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT07310082
Status
Not Yet Recruiting

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Conditions

  • Nonunion Fracture

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Autograft — PROCEDURE
    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.
  • Allograft — PROCEDURE
    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.

Study Details

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

Key Dates

Start date
Jul 31, 2026
Status verified
Dec 2025
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
156 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Autograft
    Patients randomized to autograft
  • Active Comparator: Allograft
    Patients randomized to allograft.

Primary Outcome Measure

Metabolic Equivalent for Tasks Score [ Time Frame: Week 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Atrium Health Carolinas Medical CenterCharlotteNorth Carolina28203
Rachel B Seymour, PhD
[email protected]
704-441-5365
Christine Churchill, MA
[email protected]
Madhav Karunakar, MD (SUB_INVESTIGATOR)
Laurence Kempton, MD (SUB_INVESTIGATOR)
Suman Medda, MD (SUB_INVESTIGATOR)
Kevin Phelps, MD (SUB_INVESTIGATOR)
Sarah Pierrie, MD (SUB_INVESTIGATOR)
Sophia Traven, MD (SUB_INVESTIGATOR)
Rachel B Seymour, PhD (SUB_INVESTIGATOR)
Meghan Wally, PhD (SUB_INVESTIGATOR)
Garrett Bullock, MD (SUB_INVESTIGATOR)

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By research site
Atrium Health Carolinas Medical Center· Charlotte, NC