Overview

This trial is active, not recruiting.

Conditions degenerative osteoarthritis, post-traumatic; arthrosis, rheumatoid arthritis and other inflammatory polyarthropathies, rheumatoid arthritis of subtalar joint
Treatment subtalar arthrodesis
Sponsor AlloSource
Start date June 2010
End date February 2017
Trial size 140 participants
Trial identifier NCT01413061, AlloSource Subtalar Fusion RCT

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
AlloStem is the combination of the Mesenchymal Stem Cells (MSC) derived from adipose with demineralized bone.
subtalar arthrodesis
(Active Comparator)
Autologous bone graft is recovered from the patient's own tibia or iliac crest, for transplantation in the subtalar joint.
subtalar arthrodesis

Primary Outcomes

Measure
Fusion Rate (%)(as determined by CT assessment)
time frame: 6 months post-op

Secondary Outcomes

Measure
Radiographic outcome assessments
time frame: Pre-operatively, 6 weeks, 3, 6, 12 and 24 months
Functional outcome measurements
time frame: Pre-operatively, 6 weeks, 3, 6, 12 and 24 months
Functional outcome measurements
time frame: Pre-operatively, 3, 6, 12 and 24 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

Official title Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft
Principal investigator Christiaan Coetzee, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by AlloSource.