12 Participants NeededMy employer runs this trial

Avitus Bone Harvester for Bone Grafting

ET
Overseen ByEdward T Haupt, M.D.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

ET

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

Patient must speak English or have access to sufficient translator
Patient must be able and willing to sign the IRB approved informed consent
I need a bone graft from my own body for my foot or ankle surgery.
See 5 more

Exclusion Criteria

Patient is unwilling or unable to give consent or comply with study protocol
I do not have any condition or treatment that could affect my bone marrow function.
I am 70 years old or older.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo orthopedic foot and ankle surgery with autograft bone harvest

Surgery duration

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months

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

Group I: Autograft Bone HarvestExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Zimmer Biomet

Industry Sponsor

Trials
383
Recruited
67,800+
Dr. Nitin Goyal profile image

Dr. Nitin Goyal

Zimmer Biomet

Chief Medical Officer since 2021

MD from Harvard Medical School

Ivan Tornos profile image

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.

Avitus® 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 ...