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

NCT ID: NCT06258499

Last Updated: 2024-02-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-31
• Study Completion Date: 2024-11-30

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.

Conditions

Foot Deformities

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BHA

Subjects treated with BHA + standard of care

Group Type: EXPERIMENTAL

BHA

Intervention Type: COMBINATION_PRODUCT

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

Control

Subjects treated as per standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carmell Therapeutics Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CAR-BHA- U22

Identifier Type: -

Identifier Source: org_study_id