Avitus Bone Harvester for Bone Grafting
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines a new method for collecting bone grafts using the Avitus Bone Harvester, comparing its effectiveness to other common methods. The focus is on patients requiring bone grafts for foot or ankle surgeries. Suitable candidates have been informed of their need for bone grafts for specific foot or ankle surgeries and can easily undergo knee and pelvis X-rays.
As an unphased trial, this study allows patients to contribute to innovative research that could enhance future surgical outcomes.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are using anti-rheumatologic drugs, chronic steroids, or are on antirejection meds, you may not be eligible to participate.
What prior data suggests that the Avitus Bone Harvester is safe for bone grafting?
Research has shown that the Avitus Bone Harvester is generally safe and well-tolerated by patients. In one study, patients experienced little to no pain at the donor site six weeks after the procedure, with no reports of fractures or other major issues. Another study confirmed that the device effectively collects bone and marrow for surgeries without compromising safety or effectiveness. The FDA approved the Avitus Bone Harvester, indicating it meets safety standards for its intended use. Overall, evidence suggests that the Avitus Bone Harvester is safe for patients needing bone grafts.12345
Why are researchers excited about this trial?
The Avitus® Bone Graft is unique because it offers a new way to harvest bone for grafting during orthopedic foot and ankle surgeries. Unlike traditional methods that can be invasive and painful, the Avitus Bone Harvester is designed to simplify the process and potentially reduce recovery time for patients. Researchers are excited about this approach because it could make bone grafting more efficient and less traumatic, offering a promising alternative to standard techniques that involve more extensive surgical procedures.
What evidence suggests that the Avitus Bone Harvester is effective for bone grafting?
Research has shown that the Avitus Bone Harvester is effective for bone grafting. In this trial, participants undergoing orthopedic foot and ankle surgery will have an autograft bone harvest performed using the Avitus device. This device uses a vacuum to easily collect bone and marrow, which can then be used in surgeries like foot and ankle fusions. One study found that this method was more efficient than traditional manual techniques for collecting bone. The Avitus device also reduces blood loss and shortens surgery time. Overall, it appears to be a promising tool for improving bone graft surgery outcomes.12367
Who Is on the Research Team?
Edward T. Haupt, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for adults (18-69 years old) needing bone grafts for certain foot or ankle surgeries, who are healthy enough to donate their own bone and marrow. Participants must be able to give consent, have no major bone diseases, cancer, recent transplants, infections at donor sites, or conditions that could affect the study results.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo orthopedic foot and ankle surgery with autograft bone harvest
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Avitus® Bone Graft
Trial Overview
The study compares two ways of collecting bone and marrow for grafting: using the Avitus Bone Harvester from the proximal tibia versus traditional aspiration from the iliac crest. The goal is to see if they provide similar quality material for surgery.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients undergoing an orthopedic foot and ankle surgery in which an autograft bone harvest will be performed.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Zimmer Biomet
Industry Sponsor
Dr. Nitin Goyal
Zimmer Biomet
Chief Medical Officer since 2021
MD from Harvard Medical School
Ivan Tornos
Zimmer Biomet
Chief Executive Officer since 2023
MBA from the University of Miami School of Business, BBA in Finance and International Marketing and Management from the University of Georgia Terry College of Business
Citations
Exploring versatile applications of a vacuum-assisted bone ...
This study assesses infection and clearance rates, estimated blood loss, and total procedure time associated with the use of vacuum-assisted tissue removal.
2.
zimmerbiomet.com
zimmerbiomet.com/en/products-and-solutions/specialties/biologics/avitus-bone-and-marrow-harvester.htmlAvitus® Bone and Marrow Harvester
The Avitus Bone Harvester is an easy-to-use device for efficiently harvesting autologous bone and marrow to be delivered to an orthopaedic surgical site.
Novel Vacuum-Assisted Method for Harvesting Autologous ...
We report the use of a novel vacuum-assisted curette device to harvest bone graft from the proximal tibial metaphysis for use in foot and ankle fusions.
Curettage of bone is more efficient with a vacuum-assisted ...
This study compared the Avitus® device with traditional manual curettage using modified femur bone models. A randomized crossover design was ...
Avitus Bone Harvester for Bone Grafting
This N/A medical study run by Mayo Clinic is evaluating whether Avitus® Bone Graft will have tolerable side effects & efficacy for patients with Bone Grafting.
June 26, 2023 Avitus Orthopaedics, Inc. Robert Mclain Sr ...
Bone Harvester devices, therefore, there is no negative impact on product safety or effectiveness. Mechanism of Operation. The predicate K142661 ...
(PDF) Novel Vacuum-Assisted Method for Harvesting ...
At 6 weeks after the procedure, there was minimal to no pain at the donor site, and we did not observe any fractures or other complications. Conclusions We ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.