Foot Deformities
Conditions
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.
Interventions
COMBINATION_PRODUCTBHA
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
Carmell Therapeutics Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Radiographic Fusion | 24 weeks | 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. |
Outcome results
None listed