Degenerative Osteoarthritis, Post-traumatic; Arthrosis, Rheumatoid Arthritis of Subtalar Joint, Rheumatoid Arthritis & Other Inflammatory Polyarthropathies
Conditions
Keywords
Other Hindfoot Conditions requiring Subtalar Arthrodesis, Post-traumatic Arthritis
Brief summary
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.
Interventions
PROCEDURESubtalar Arthrodesis
Sponsors
AlloSource
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Must be diagnosed with degenerative osteoarthritis, post-traumatic arthritis, inflammatory arthritis (ie: rheumatoid arthritis) or other conditions of the hindfoot requiring subtalar arthrodesis. 2. Patients must be able to attend follow-up examinations for the duration of the trial. 3. The patient is at least 18 years of age and skeletally mature, or less than 80 years of age at the time of surgery. 4. Is willing and able to comply with the clinical trial plan and able to understand and sign the Patient Informed Consent Form.
Exclusion criteria
1. Younger than 18 years old or older than 80 years old. 2. Has a condition that prevents ambulation or completion of any of the trial measurements. 3. 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. 4. Has treatment planned for the arthrodesis which does not require the use of screws. 5. Has any active infection of the hindfoot, a systemic infection or bacteremia. 6. Has received any treatment within the past 12 months which may interfere with bone metabolism \[bisphosphonates (Fosamax, Actonel, Boniva, Reclast) and calcitonin (Miacalcin)\]. 7. Is scheduled to have any surgical procedure on the contralateral foot within 6 weeks before or after the study procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fusion Rate (%)(as determined by CT assessment) | 6 months post-op | Fusion Rate (%)(as determined by CT assessment) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic outcome assessments | Pre-operatively, 6 weeks, 3, 6, 12 and 24 months | Radiographic outcome assessments |
| Functional outcome measurements | Pre-operatively, 6 weeks, 3, 6, 12 and 24 months | FFI-R, SF-12 |
Countries
United States
Outcome results
None listed