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

NCT06258499 | Withdrawn Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: CAR-BHA- U22
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

BHA

EXPERIMENTAL

Subjects treated with BHA + standard of care

Combination Product: BHA

Control

NO INTERVENTION

Subjects treated as per standard of care

Interventions

BHA 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.

BHA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carmell Therapeutics Corporation: lead

MeSH Terms

Conditions

Foot Deformities

Interventions

Butylated Hydroxyanisole

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Anisoles; Methyl Ethers; Ethers; Organic Chemicals; Phenyl Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 14, 2024
• Study Start: March 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: November 1, 2024
• Last Updated: February 14, 2024

Record last verified: 2024-02