Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft

Study Overview
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Brief Summary
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The purpose of this clinical trial is to evaluate the outcome of implanting AlloStem® graft with appropriate rigid internal fixation hardware as an alternative to autograft bone graft with rigid fixation in subtalar arthrodesis procedures. The primary objective of this clinical trial is to compare the overall fusion rate of the investigational to the control treatment. Fusion will be determined by clinical findings, radiographs and computed tomography (CT) of the subtalar joint 24 weeks (6 months) after the trial surgery.

Official Title
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Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft

Conditions
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Degenerative Osteoarthritis, Post-traumatic; Arthrosis, Rheumatoid Arthritis & Other Inflammatory Polyarthropathies, Rheumatoid Arthritis of Subtalar Joint

Intervention / Treatment
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* Procedure: Subtalar Arthrodesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be diagnosed with degenerative osteoarthritis, post-traumatic arthritis, inflammatory arthritis (ie: rheumatoid arthritis) or other conditions of the hindfoot requiring subtalar arthrodesis. Patients must be able to attend follow-up examinations for the duration of the trial. The patient is at least 18 years of age and skeletally mature, or less than 80 years of age at the time of surgery. Is willing and able to comply with the clinical trial plan and able to understand and sign the Patient Informed Consent Form. Exclusion Criteria: Younger than 18 years old or older than 80 years old. Has a condition that prevents ambulation or completion of any of the trial measurements. Requires fusion of additional hindfoot or ankle joints simultaneously (i.e. a pantalar, tibiotalocalcaneal or triple arthrodesis). Concomitant midfoot or forefoot procedures, such as osteotomies, tendon or metatarsal procedures are not exclusionary. Has treatment planned for the arthrodesis which does not require the use of screws. Has any active infection of the hindfoot, a systemic infection or bacteremia. Has received any treatment within the past 12 months which may interfere with bone metabolism [bisphosphonates (Fosamax, Actonel, Boniva, Reclast) and calcitonin (Miacalcin)]. Is scheduled to have any surgical procedure on the contralateral foot within 6 weeks before or after the study procedure.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AlloStem Live Cellular Allograft<br>AlloStem is the combination of the Mesenchymal Stem Cells (MSC) derived from adipose with demineralized bone. | Procedure: Subtalar Arthrodesis<br> <br> |
| Active Comparator: Control: Autologous Bone Marrow Aspirate<br>Autologous bone graft is recovered from the patient's own tibia or iliac crest, for transplantation in the subtalar joint. | Procedure: Subtalar Arthrodesis<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion Rate (%)(as determined by CT assessment) | Fusion Rate (%)(as determined by CT assessment) | 6 months post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic outcome assessments | Radiographic outcome assessments | Pre-operatively, 6 weeks, 3, 6, 12 and 24 months | 
| Functional outcome measurements | FFI-R, SF-12 | Pre-operatively, 6 weeks, 3, 6, 12 and 24 months | 
| Functional outcome measurements | AOFAS | Pre-operatively, 3, 6, 12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Other Hindfoot Conditions requiring Subtalar Arthrodesis, Post-traumatic Arthritis