Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01413061 |
Recruitment Status :
Completed
First Posted : August 10, 2011
Last Update Posted : April 13, 2018
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Condition or disease | Intervention/treatment | Phase |
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Degenerative Osteoarthritis Post-traumatic; Arthrosis Rheumatoid Arthritis & Other Inflammatory Polyarthropathies Rheumatoid Arthritis of Subtalar Joint | Procedure: Subtalar Arthrodesis | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 140 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft |
Actual Study Start Date : | June 2010 |
Actual Primary Completion Date : | February 2017 |
Actual Study Completion Date : | March 2018 |
Arm | Intervention/treatment |
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Active Comparator: AlloStem Live Cellular Allograft
AlloStem is the combination of the Mesenchymal Stem Cells (MSC) derived from adipose with demineralized bone.
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Procedure: Subtalar Arthrodesis |
Active Comparator: Control: Autologous Bone Marrow Aspirate
Autologous bone graft is recovered from the patient's own tibia or iliac crest, for transplantation in the subtalar joint.
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Procedure: Subtalar Arthrodesis |
- Fusion Rate (%)(as determined by CT assessment) [ Time Frame: 6 months post-op ]Fusion Rate (%)(as determined by CT assessment)
- Radiographic outcome assessments [ Time Frame: Pre-operatively, 6 weeks, 3, 6, 12 and 24 months ]Radiographic outcome assessments
- Functional outcome measurements [ Time Frame: Pre-operatively, 6 weeks, 3, 6, 12 and 24 months ]FFI-R, SF-12
- Functional outcome measurements [ Time Frame: Pre-operatively, 3, 6, 12 and 24 months ]AOFAS

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01413061
United States, Maryland | |
Institute for Foot and Ankle Reconstruction at Mercy | |
Baltimore, Maryland, United States, 21202 | |
United States, Michigan | |
Orthopaedic Associates of Michigan | |
Grand Rapids, Michigan, United States, 49525 | |
United States, Minnesota | |
Minnesota Orthopedic Sports Medicine Institute (MOSMI) | |
Edina, Minnesota, United States, 55435 | |
United States, Pennsylvania | |
Penn State Milton S. Hershey Medical Center | |
Hershey, Pennsylvania, United States, 17033 | |
United States, Tennessee | |
Campbell Clinic | |
Germantown, Tennessee, United States, 38138 |
Principal Investigator: | Christiaan Coetzee, MD | Minnesota Orthopedic Sports Medicine Institute (MOSMI) | |
Principal Investigator: | Mark Myerson, MD | Institute for Foot and Ankle Reconstruction at Mercy | |
Principal Investigator: | John Anderson, MD | Orthopaedic Associates of Michigan | |
Principal Investigator: | Paul Juliano, MD | Milton S. Hershey Medical Center | |
Principal Investigator: | Andrew Murphy, MD | Campbell Clinic |
Responsible Party: | AlloSource |
ClinicalTrials.gov Identifier: | NCT01413061 |
Other Study ID Numbers: |
AlloSource Subtalar Fusion RCT |
First Posted: | August 10, 2011 Key Record Dates |
Last Update Posted: | April 13, 2018 |
Last Verified: | April 2018 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Other Hindfoot Conditions requiring Subtalar Arthrodesis Post-traumatic Arthritis |
Arthritis Osteoarthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |