Mayo clinic tests new bone graft method against standard approach
NCT ID NCT07434505
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two methods of collecting bone graft material: from the pelvic bone (iliac crest) and from the shin bone (proximal tibia) using a product called Avitus. Researchers want to see if the cells and bone-growth factors from the shin are as good as those from the pelvis. The study involves 12 adults who need bone graft for foot or ankle surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Nov 2025
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient must be 18 years of age or older. * Patient must be able and willing to sign the IRB approved informed consent. * Patient must consent to preoperative knee and pelvis radiographs to confirm no issue at harvest location. * Patient has indication for autograft bone harvest (undergoing any ankle or hindfoot fusion, complex mid and forefoot fusions requiring graft supplementation, treatment of fuse and fracture nonunions) * Patient is indicated for proximal tibia autograft harvest and iliac crest BMA (e.g. no hx bilateral TKAs or previous iliac wing trauma bilaterally). * Patient is skeletally "mature" and presents with no concern for osteopenia/osteoporosis. * Patient has sufficient volume of harvest material for study inclusion (minimum of 10 ml of cancellous bone graft plus 10 ml fluid pressed out from cancellous bone portion) * Patient must speak English or have access to sufficient translator. Exclusion Criteria: * Patient is 70 yrs of age or older. * Patient is unwilling or unable to give consent or comply with study protocol. * Patient has any condition, which in the judgement of the Investigator, places the patient at undue risk or interferes with the study. * Patient has mental or neurological disorder that will not allow for proper informed consent. * Patient is known to be pregnant or breastfeeding. * Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, and/or anticipated to be non-compliant). * Patient has any condition, which in the judgement of the Investigator, may chemically skew bone marrow. This may include but is not limited to the following: * Cancer * Undergoing chemotherapy radiation, * Bone marrow transplant * Infection at the donor sites * Organ transplant on antirejection meds * Usage of anti-rheumatologic drugs * Chronic steroid usage * Anemia * Myelodysplastic Syndromes * Patient presents with arthritis of the knee and may require knee replacement within the next 12 months.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Bone graft are added.
Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Mayo Clinic
RECRUITINGJacksonville, Florida, 32224, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Diabetes drug may boost dental implant success, small study finds
- New gum grafting method studied in 16 patients – no treatment given
- New bone graft aims to improve dental implant success
- Olive oil gel could replace bone grafts in dental implants
- Can a collagen patch improve gum healing after dental bone grafts?
- New bone graft blend could improve dental implant success