Autograft vs Allograft for Nonunion Fracture
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether an autograft or allograft helps individuals with nonunion fractures return to normal activities more quickly. Nonunion fractures are breaks in bones like the tibia, femur, or humerus that have not healed properly over time. Participants will receive either an autograft (bone from their own body) or an allograft (bone from a donor) to determine which method promotes faster recovery. Ideal candidates for this trial are those who have undergone surgery to fix a long bone fracture that remains unhealed after five months, particularly if there is a visible gap in the bone exceeding 5 cm. As an unphased trial, this study provides a unique opportunity to contribute to medical knowledge and potentially discover a faster recovery solution for nonunion fractures.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that both autograft and allograft treatments are used for fractures that don't heal properly, with some differences in safety. An autograft involves taking bone from another part of the patient's own body and usually carries a lower risk of infection. One study found the infection rate for autografts to be about 12.4%.
In contrast, allografts use bone from a donor and had a higher infection rate of around 26%. However, this does not mean allografts are unsafe. Many patients using allografts heal well, with their bones joining together within six months.
These findings suggest that while both treatments are generally safe, autografts might offer a slight advantage in terms of lower infection risk. Patients should always discuss with their doctor what’s best for their situation.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for nonunion fractures because they explore two different grafting methods: autografts and allografts. Unlike the standard of care, which often involves metal fixation or bone stimulators, autografts use the patient's own bone tissue, potentially reducing rejection risks and enhancing integration with existing bone. Allografts, on the other hand, use bone from a donor, which can be more readily available and avoids the need for an additional surgical site on the patient. Both approaches aim to improve healing in fractures that haven't united, offering alternative solutions when traditional methods might fall short.
What evidence suggests that this trial's treatments could be effective for nonunion fracture?
This trial will compare the effectiveness of autografts and allografts for treating nonunion fractures. Studies have shown that both treatments are effective. Participants in the autograft arm, which uses bone grafts from the patient's own body, may heal faster, typically between 198 and 225 days. In contrast, participants in the allograft arm, which uses bone grafts from a donor, may take longer to heal but still achieve a high success rate. One study found that allografts helped most patients heal within three to six months. Additionally, autografts have a higher success rate after just one surgery, with 95.6% of cases healing successfully. Both treatments show strong potential in effectively helping patients recover from nonunion fractures.12467
Who Is on the Research Team?
Joseph R Hsu, MD
Principal Investigator
Wake Forest University Health Sciences
Are You a Good Fit for This Trial?
This trial is for adults over 18 with a nonunion fracture in long bones (tibia, femur, humerus) that have a bone gap of more than 5cm. They should be scheduled for surgery at least five months after the initial fracture fixation and must speak English or Spanish. Those with active infections, BMI over 50, unstable living situations, or prisoners are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either autograft or allograft for nonunion fracture treatment
Follow-up
Participants complete follow-up surveys and assessments to monitor recovery and return to work
Long-term Follow-up
Participants are monitored for long-term outcomes such as union percentage and complications
What Are the Treatments Tested in This Trial?
Interventions
- Allograft
- Autograft
Trial Overview
The study compares two methods to treat nonunion fractures: using an autograft (patient's own bone tissue) versus an allograft (donor bone tissue). The goal is to see which treatment helps patients return to their activities faster.
How Is the Trial Designed?
2
Treatment groups
Active Control
Patients randomized to autograft
Patients randomized to allograft.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
Citations
Outcomes and complication rates of different bone grafting ...
The present study was designed to analyze the efficacy of distinct adjunctive bone grafting modalities for surgical revisions of long bone ...
NCT07310082 | Allograft vs. Autograft Nonunion
The purpose of this research study is to find out if patients treated for nonunion fracture with autograft or allograft return to activity ...
Functional and Radiological Outcomes of Allograft ...
In this study, radiological signs of union were achieved in most patients within three to six months following allograft-assisted fixation of ...
Fracture nonunion in long bones: A literature review of risk ...
A meta-analysis of humeral nonunions identified 36 studies of 672 patients treated with plate fixation and bone grafting with a reported union rate of 98% [74].
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orthopedicreviews.openmedicalpublishing.org
orthopedicreviews.openmedicalpublishing.org/article/115603-radiographical-outcomes-of-a-cellular-based-allograft-following-foot-ankle-arthrodesis-in-patients-with-risk-for-non-unionRadiographical outcomes of a cellular based allograft ...
A retrospective study reported a 97% fusion success among the patients who underwent arthrodesis surgery using the distal tibia bone graft ( ...
A systematic scoping review of the latest data on ...
All the remaining patients achieved successful fracture bone union within 6 months. All persistent non-union had received a combination of ICBG and BMP. Among ...
Long bone uninfected non-union: grafting techniques in
Infected non-unions can be estimated in 1–2 out of 10. The fracture healing cascade may be disturbed or disrupted in those cases, ultimately ...
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