By InvitationNot Applicable

Induce XT™ Bone Graft in Foot and Ankle Fusion

Canada60 participantsStarted 2025-05-12

Plain-language summary

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 material used in surgeries to fill gaps where bone is missing, such as during foot and ankle fusion. Participants in the study will have a screening visit to determine eligibility, followed by an assessment on the day of surgery and 5 follow-up visits over 12 months. These visits will include X-rays, pain evaluations, and questionnaires.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patient has a bone defect in the hindfoot or ankle; and
✓. Is requiring fusion using an open surgical technique with supplemental bone graft/substitute; and
✓. Fusion site is able to be rigidly stabilized with no more than 3 screws across the fusion site; and
✓. Patient is requiring one of the following procedures:

Exclusion criteria

✕. Patient is under 18 years of age at the time of consent;
✕. Patient has an active (local or systemic) infection or is undergoing adjunctive treatment for infection;
✕. Patient has previous fusion surgery of the proposed fusion site;
✕. Patient has cognitive disorders or is unable to complete questionnaires or provide consent.

What they're measuring

Bone Fusion

Timeframe: At 24 and 52 weeks

Percent bridging bone

Timeframe: At 24 and 52 weeks

Trial details

NCT IDNCT06662266

SponsorRed Rock Regeneration Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-11-01

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