Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft (NCT01413061) | Clinical Trial Compass
CompletedNot Applicable
Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft
United States140 participantsStarted 2010-06
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.