NCT Number: NCT01413061
Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft
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.
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Notify MeKey information
Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Institute for Foot and Ankle Reconstruction at Mercy, Baltimore, Maryland, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Fusion Rate (%)(as determined by CT assessment)
Time frame: 6 months post-op
Fusion Rate (%)(as determined by CT assessment)
Secondary outcomes
-
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
Sponsors and collaborators
Lead sponsor
AlloSource
Industry
Registry information
Important dates
- Study start
- 2010
- Primary completion
- 2017
- Study completion
- 2018
- First posted
- Aug 10, 2011
- Registry last updated
- Apr 13, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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