Induce XT™ Bone Graft for Foot and Ankle Surgery

Overseen By Sean Peel, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Red Rock Regeneration Inc.

Disqualifiers: Under 18, Infection, Previous fusion, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a bone graft material called Induce XT for individuals undergoing foot or ankle surgery. It aims to fill gaps where bone is missing, particularly when fusion is necessary. Researchers will monitor participants using X-rays, pain assessments, and simple surveys. This trial suits those requiring specific foot or ankle fusion surgeries, such as ankle joint fusion or triple arthrodesis, where up to three screws can stabilize the bones. As an unphased trial, it provides an opportunity to advance medical techniques in bone grafting for foot and ankle surgeries.

What prior data suggests that Induce XT™ Bone Graft is safe for foot and ankle surgery?

Research shows that Induce XT™ Bone Graft is generally well-tolerated in foot and ankle surgeries. Studies have found that similar bone graft materials successfully help bones heal and fuse. For instance, one study reported a 97% success rate in patients who underwent foot and ankle surgeries with a similar bone graft. This suggests the treatment is effective and likely safe for most people.

The Induce XT™ Bone Graft is a human allograft, made from donated human tissue. It contains natural growth factors from human bone that aid in bone healing. While specific safety data for Induce XT™ is limited, similar grafts used in surgeries have not shown significant adverse effects, suggesting the treatment could be safe for use in humans.

This trial is in a phase that does not focus solely on safety, indicating that some safety testing has already occurred. If the treatment were unsafe, it likely wouldn't be in this trial phase. Participants considering this trial might find this reassuring, but discussing personal health conditions with a healthcare provider before joining any clinical trial is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Induce XT™ Bone Graft is unique because it uses a synthetic bone grafting material that is designed to promote bone growth in foot and ankle surgeries, specifically for procedures like hindfoot or ankle arthrodesis. Unlike traditional bone grafts, which often source material from the patient’s own body or a donor, Induce XT™ provides a consistent and readily available alternative that can reduce recovery time and minimize complications associated with graft harvesting. Researchers are excited about this treatment because it has the potential to enhance bone fusion rates and improve patient outcomes with less invasive means.

What evidence suggests that Induce XT™ Bone Graft is effective for foot and ankle surgery?

Studies have shown that bone grafts like Induce XT, which participants in this trial may receive, can help bones heal properly after surgery. Research indicates that similar products have a 97% success rate in aiding bone fusion in foot and ankle surgeries. Induce XT is a donor bone graft containing natural proteins called growth factors. These proteins signal cells to grow and heal, promoting bone regeneration and bonding during recovery. This type of graft has successfully supported bone healing and improved surgical outcomes in many cases. Overall, evidence suggests that Induce XT could effectively aid bone fusion in foot and ankle surgeries. ^{1 2 3 5 6}

Who Is on the Research Team?

Sean Peel

Principal Investigator

Red Rock Regeneration Inc.

Are You a Good Fit for This Trial?

This trial is for patients needing foot or ankle surgery due to deformities or arthritis, who can have their fusion sites stabilized with screws. It's not suitable for those requiring different surgical techniques or stabilization methods.

Inclusion Criteria

My fusion site can be securely fixed with up to 3 screws.

I have a bone defect in my hindfoot or ankle.

I need a spine fusion surgery with bone graft using an open method.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Surgery

Participants undergo foot and/or ankle fusion surgery using Induce XT bone graft

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, including X-rays, pain evaluations, and questionnaires

52 weeks

5 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Induce XT™ Bone Graft

Trial Overview The study tests Induce XT™ Bone Graft, a mix of human bone fibers and proteins, in foot/ankle surgeries. Participants will be monitored through X-rays and pain assessments over a year after the surgery.

How Is the Trial Designed?

Group I: Diverse group of participants who require hindfoot or ankle arthrodesis Experimental Treatment 1 Intervention

The selection criteria are designed to ensure that the study population represents the typical patients undergoing these procedures.

Who Is Running the Clinical Trial?

Red Rock Regeneration Inc.

Lead Sponsor

Trials

1

Recruited

60+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06662266

Induce XT™ Bone Graft in Foot and Ankle Fusion The goal of this study is to evaluate how effective Induce XT is in patients undergoing foot and/or ankle surgery. Induce XT is a bone graft ...

2. inducext.com inducext.com/

InduceXT Advanced Bone Regeneration Technology Developed for Foot & Ankle Surgery. InduceXT is a human allograft which contains multiple growth factors naturally ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39351126/

Clinical and Radiographic Outcomes After Hindfoot ... The purpose of this study was to prospectively evaluate the early efficacy and safety of cellular bone allograft use in hindfoot and ankle ...

4. 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-union

Radiographical 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 ( ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11068146/

Comparative Studies of Bone Graft and Orthobiologics for ... Bone grafts used to aid in hindfoot and/or ankle arthrodesis procedures have been shown to contribute to successful fusion and favorable ...

6. openorthopaedicsjournal.com openorthopaedicsjournal.com/VOLUME/18/ELOCATOR/e18743250283784/PDF/

Ankle Fusion Rates using Composite Peptide This study aims to investigate joint fusion rates using Composite Peptide. Enhanced Bone Graft (CPEBG) as an adjunct during ankle fusion surgery ...