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Not Yet Recruiting
NCT07310082
Allograft vs. Autograft Nonunion
Conditions: Nonunion Fracture
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 156
Sponsor: Wake Forest University Health Sciences
Location: Atrium Health Carolinas Medical Center Charlotte North Carolina
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07310082). StuddyBuddy aggregates publicly available trial information.