Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft

Completed · Not applicable

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

In brief

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.

Key facts

Study ID

NCT01413061

Run by

AlloSource

People needed

140

Starts

2010-06-01

Expected to finish

2018-03-01

Last updated by the study team

2018-04-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Institute for Foot and Ankle Reconstruction at Mercy — Baltimore, Maryland, United States
• Orthopaedic Associates of Michigan — Grand Rapids, Michigan, United States
• Minnesota Orthopedic Sports Medicine Institute (MOSMI) — Edina, Minnesota, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Campbell Clinic — Germantown, Tennessee, United States

Full record on ClinicalTrials.gov

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