A Multicenter, Randomized, Controlled, Blinded Study of the Safety and Efficacy of Bone Healing Accelerant Versus Autologous Bone Grafting in Subjects Undergoing Hindfoot or Ankle Arthrodesis and Who Require Supplementary Grafting

Carmell Therapeutics Corporation0 sitesMarch 2024

ConditionsFoot Deformities

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Foot Deformities
Sponsor: Carmell Therapeutics Corporation
Primary Endpoint: Successful Radiographic Fusion
Status: Withdrawn
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This study is being conducted to demonstrate the safety and effectiveness of Bone Healing Accelerant (BHA) product when applied to the joint space of the ankle of hindfoot (the section of the foot immediately below the ankle joint) during fusion surgery. It is hypothesized that by 6 months, the number of subjects with successful bone fusion will be greater in the BHA-treated group compared to subjects treated with standard of care alone.

Registry

clinicaltrials.gov

Start Date

March 2024

End Date

November 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Carmell Therapeutics Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient has pain with weight-bearing in the joint(s) below that, in the opinion of the Investigator, warrants arthrodesis:
•Tibiotalar (ankle)
•Talocalcaneal (subtalar)
•Talonavicular
•Calcaneocuboid
•Double hindfoot (e.g., talonavicular and talocalcaneal joints)
•Triple hindfoot (subtalar, talonavicular and calcaneocuboid joints
•Joint space(s) can, in the opinion of the Investigator, be adequately filled with no more than 9 cc of graft material (BHA or ABG)
•Each fused joint can be adequately compressed and rigidly stabilized with plates, screws, staples or a combination thereof. External fixation, percutaneous Kirschner wires or intramedullary rods may not be used.
•Patient is willing and able to comply with all study requirements including all postoperative clinical and radiographic evaluations.

Exclusion Criteria

•Skeletally immature patients (i.e., radiographic evidence of open physes), regardless of age
•Bone deficit, defect or void requiring a structural graft
•Condition requiring intramedullary nailing or external fixation for the arthrodesis
•Condition requiring osteotomy or fusion of any midfoot joints.
•Prior arthroplasty, arthrodesis, major surgical repair or reconstruction of the index ankle or hindfoot joints.

Outcomes

Primary Outcomes

Successful Radiographic Fusion

Time Frame: 24 weeks

Greater than or equal to 50% bone bridging across joint space for the full complement of joints fused as determined by CT in the absence of secondary surgical or nonsurgical interventions intended to promote fusion.