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Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01413061
Recruitment Status : Completed
First Posted : August 10, 2011
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
AlloSource

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Degenerative Osteoarthritis Post-traumatic; Arthrosis Rheumatoid Arthritis & Other Inflammatory Polyarthropathies Rheumatoid Arthritis of Subtalar Joint Procedure: Subtalar Arthrodesis Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft
Actual Study Start Date : June 2010
Actual Primary Completion Date : February 2017
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: AlloStem Live Cellular Allograft
AlloStem is the combination of the Mesenchymal Stem Cells (MSC) derived from adipose with demineralized bone.
 Procedure: Subtalar Arthrodesis
Active Comparator: 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.
 Procedure: Subtalar Arthrodesis


Outcome Measures
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Primary Outcome Measures :
  1. Fusion Rate (%)(as determined by CT assessment) [ Time Frame: 6 months post-op ]
    Fusion Rate (%)(as determined by CT assessment)


Secondary Outcome Measures :
  1. Radiographic outcome assessments [ Time Frame: Pre-operatively, 6 weeks, 3, 6, 12 and 24 months ]
    Radiographic outcome assessments

  2. Functional outcome measurements [ Time Frame: Pre-operatively, 6 weeks, 3, 6, 12 and 24 months ]
    FFI-R, SF-12

  3. Functional outcome measurements [ Time Frame: Pre-operatively, 3, 6, 12 and 24 months ]
    AOFAS


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01413061


Locations
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United States, Maryland
Institute for Foot and Ankle Reconstruction at Mercy
Baltimore, Maryland, United States, 21202
United States, Michigan
Orthopaedic Associates of Michigan
Grand Rapids, Michigan, United States, 49525
United States, Minnesota
Minnesota Orthopedic Sports Medicine Institute (MOSMI)
Edina, Minnesota, United States, 55435
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, Tennessee
Campbell Clinic
Germantown, Tennessee, United States, 38138
Sponsors and Collaborators
AlloSource
Investigators
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Principal Investigator: Christiaan Coetzee, MD Minnesota Orthopedic Sports Medicine Institute (MOSMI)
Principal Investigator: Mark Myerson, MD Institute for Foot and Ankle Reconstruction at Mercy
Principal Investigator: John Anderson, MD Orthopaedic Associates of Michigan
Principal Investigator: Paul Juliano, MD Milton S. Hershey Medical Center
Principal Investigator: Andrew Murphy, MD Campbell Clinic
More Information
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Responsible Party: AlloSource
ClinicalTrials.gov Identifier: NCT01413061    
Other Study ID Numbers: AlloSource Subtalar Fusion RCT
First Posted: August 10, 2011    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AlloSource:
Other Hindfoot Conditions requiring Subtalar Arthrodesis
Post-traumatic Arthritis
Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases