Induce XT™ Bone Graft in Foot and Ankle Fusion

NCT06662266 | Enrolling By Invitation

• 1 other identifier: CT-NMP-005
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgery; Foot Deformities; Ankle Arthropathy

Outcome Measures

Primary Outcomes (2)

• Bone Fusion

  Fusion as measured by X-Ray

  At 24 and 52 weeks

• Percent bridging bone

  Measured by Computerized Tomography (CT)

  At 24 and 52 weeks

Secondary Outcomes (2)

• Disability score for foot and ankle condition

  At 24 and 52 weeks

• Patient reported health survey

  At 24 and 52 weeks

Other Outcomes (4)

• Pain upon weight bearing

  At 24 and 52 weeks

• Pain at fusion site

  At 24 and 52 weeks

• Device related Serious Adverse Events

  Day of Surgery up to 52 weeks

Study Arms (1)

Diverse group of participants who require hindfoot or ankle arthrodesis

OTHER

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

Device: Induce XT™ is a mixture of human cortical bone fibers and microparticulates that have been processed into Natural Matrix Protein® (NMP®) to which cancellous bone microparticulates have been added

Interventions

Induce XT™ is a mixture of human cortical bone fibers and microparticulates that have been processed into Natural Matrix Protein® (NMP®) to which cancellous bone microparticulates have been added DEVICE

Bone graft material is required for successful foot and ankle fusion surgery. Current bone grafting materials include autogenous bone, Augment Bone Graft and demineralized bone matrix (DBM), each of which have limitations. Induce XT is a novel bone graft material that can potentially be used in foot and ankle fusions that may overcome some of these limitations.

Diverse group of participants who require hindfoot or ankle arthrodesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients meeting all of the following criteria will be considered eligible for study participation:
• 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:
• Ankle joint fusion
• Subtalar fusion
• Calcaneocuboid fusion
• Talonavicular fusion
• Triple arthrodesis (subtalar, talonavicular and calcaneocuboid joints)
• Double fusions (talonavicular and calcaneocuboid joints).

You may not qualify if:

• Patient meeting any of the following criteria will be excluded from study participation:
• 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.

Sponsors & Collaborators

• Red Rock Regeneration Inc.: lead

Study Sites (1)

Halifax Infirmary

Halifax, Nova Scotia, B3H A36, Canada

Location

MeSH Terms

Conditions

Foot Deformities

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

• Sean Peel

  Red Rock Regeneration Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 28, 2024
• Study Start: May 12, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)