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New bone graft could improve foot and ankle surgery outcomes

NCT ID NCT06662266

Disease control Sponsor: Red Rock Regeneration Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a new bone graft material called Induce XT in 60 people undergoing foot or ankle fusion surgery. The graft is made from processed human bone and is meant to help the bones heal together. Participants will be followed for 12 months with X-rays, CT scans, and questionnaires to see how well the bone fuses and how their recovery goes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Induce XT (a mixture of processed human cortical and cancellous bone particles)
What this could lead to
If it works, Induce XT could provide a safer, more effective bone graft option for foot and ankle fusion surgeries, reducing the need for harvesting the patient's own bone.
What could go wrong
This is an early-stage study with only 60 participants and no comparison group, so results may not be conclusive. The bone graft may not fuse as well as existing options, and there are standard surgical risks like infection or non-union.

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 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients meeting all of the following criteria will be considered eligible for study participation: 1. Patient has a bone defect in the hindfoot or ankle; and 2. Is requiring fusion using an open surgical technique with supplemental bone graft/substitute; and 3. Fusion site is able to be rigidly stabilized with no more than 3 screws across the fusion site; and 4. Patient is requiring one of the following procedures: * Ankle joint fusion * Subtalar fusion * Calcaneocuboid fusion * Talonavicular fusion * Triple arthrodesis (subtalar, talonavicular and calcaneocuboid joints) * Double fusions (talonavicular and calcaneocuboid joints). Exclusion Criteria: * Patient meeting any of the following criteria will be excluded from study participation: 1. Patient is under 18 years of age at the time of consent; 2. Patient has an active (local or systemic) infection or is undergoing adjunctive treatment for infection; 3. Patient has previous fusion surgery of the proposed fusion site; 4. Patient has cognitive disorders or is unable to complete questionnaires or provide consent.

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Conditions

The condition(s) this trial relates to.

arthropathy Foot Deformities

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ankle arthropathy Foot deformities Surgery

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. 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

  • Halifax Infirmary

    Halifax, Nova Scotia, B3H A36, Canada

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