NCT06258499

Bone Healing Accelerant (BHA) Versus Autologous Bone Grafting (ABG) for Hindfoot or Ankle Arthrodesis

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Carmell Therapeutics Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Foot Deformities

Interventions

Type	Name	Description
COMBINATION_PRODUCT	BHA	BHA active ingredients include a blood-derived component and beta-tricalcium phosphate. It is manually placed into the joint fusion space during fusion surgery.

Timeline

• Start date: 2024-03-01
• Primary completion: 2024-09-01
• Completion: 2024-11-01
• First posted: 2024-02-14
• Last updated: 2024-02-14

Regulatory

• FDA-regulated drug study
• FDA-regulated device study