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

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.

Study Overview

• Status: Withdrawn
• Conditions: Foot Deformities
• Intervention / Treatment: Combination product: BHA

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient has pain with weight-bearing in the joint(s) below that, in the opinion of the Investigator, warrants arthrodesis:

  1. Tibiotalar (ankle)
  2. Talocalcaneal (subtalar)
  3. Talonavicular
  4. Calcaneocuboid
  5. Double hindfoot (e.g., talonavicular and talocalcaneal joints)
  6. 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.
• If patient is a woman of childbearing bearing potential (not post-menopausal for 12 months or surgically sterile), patient has a urine pregnancy test with a negative result at screening and on the day of surgery, prior to the procedure. These trial participants must commit to adequate birth control through the 52-week follow-up

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BHA; Subjects treated with BHA + standard of care	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.
No Intervention: Control; Subjects treated as per standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful Radiographic Fusion	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.	24 weeks

Collaborators and Investigators

• Sponsor: Carmell Therapeutics Corporation

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 6, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Lower Extremity Deformities, Congenital; Foot Deformities; Foot Deformities, Congenital
• Other Study ID Numbers: CAR-BHA- U22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes