Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft
Status: | Completed |
---|---|
Conditions: | Arthritis, Osteoarthritis (OA), Orthopedic |
Therapuetic Areas: | Rheumatology, Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 4/17/2018 |
Start Date: | June 2010 |
End Date: | March 2018 |
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.
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.
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.
We found this trial at
5
sites
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500 University Dr
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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