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Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AlloSource
ClinicalTrials.gov Identifier:
NCT01413061
First received: August 8, 2011
Last updated: November 24, 2014
Last verified: November 2014
  Purpose

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 Intervention
Degenerative Osteoarthritis
Post-traumatic; Arthrosis
Rheumatoid Arthritis and Other Inflammatory Polyarthropathies
Rheumatoid Arthritis of Subtalar Joint
Procedure: Subtalar Arthrodesis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft

Resource links provided by NLM:


Further study details as provided by AlloSource:

Primary Outcome Measures:
  • Fusion Rate (%)(as determined by CT assessment) [ Time Frame: 6 months post-op ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Radiographic outcome assessments [ Time Frame: Pre-operatively, 6 weeks, 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Functional outcome measurements [ Time Frame: Pre-operatively, 6 weeks, 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
    FFI-R, SF-12

  • Functional outcome measurements [ Time Frame: Pre-operatively, 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
    AOFAS


Enrollment: 140
Study Start Date: June 2010
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01413061

Locations
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
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

No publications provided

Responsible Party: AlloSource
ClinicalTrials.gov Identifier: NCT01413061     History of Changes
Other Study ID Numbers: AlloSource Subtalar Fusion RCT
Study First Received: August 8, 2011
Last Updated: November 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by AlloSource:
Other Hindfoot Conditions requiring Subtalar Arthrodesis
Post-traumatic Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Osteoarthritis
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 25, 2014