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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
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
Fusion Rate (%)(as determined by CT assessment)
Fusion Rate (%)(as determined by CT assessment)
Time frame: 6 months post-op
Radiographic outcome assessments
Radiographic outcome assessments
Time frame: Pre-operatively, 6 weeks, 3, 6, 12 and 24 months
Functional outcome measurements
FFI-R, SF-12
Time frame: Pre-operatively, 6 weeks, 3, 6, 12 and 24 months
Functional outcome measurements
AOFAS
Time frame: Pre-operatively, 3, 6, 12 and 24 months
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