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

NCT06258499 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-02-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Carmell Therapeutics Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-31
Primary Completion
2024-09-30
Completion
2024-11-30
FDA Drug
Yes
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06258499 on ClinicalTrials.gov