Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2018-03-31

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AlloStem Live Cellular Allograft

AlloStem is the combination of the Mesenchymal Stem Cells (MSC) derived from adipose with demineralized bone.

Group Type ACTIVE_COMPARATOR

Subtalar Arthrodesis

Intervention Type PROCEDURE

Control: Autologous Bone Marrow Aspirate

Autologous bone graft is recovered from the patient's own tibia or iliac crest, for transplantation in the subtalar joint.

Group Type ACTIVE_COMPARATOR

Subtalar Arthrodesis

Intervention Type PROCEDURE

Interventions

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Subtalar Arthrodesis

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No