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.

Study Overview

• Status: Completed
• Conditions: Post-traumatic; Arthrosis; Degenerative Osteoarthritis; Rheumatoid Arthritis & Other Inflammatory Polyarthropathies; Rheumatoid Arthritis of Subtalar Joint
• Intervention / Treatment: Procedure: Subtalar Arthrodesis

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Institute for Foot and Ankle Reconstruction at Mercy
  • Michigan
    • Grand Rapids, Michigan, United States, 49525
      • Orthopaedic Associates of Michigan
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Minnesota Orthopedic Sports Medicine Institute (MOSMI)
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Campbell Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusion Rate (%)(as determined by CT assessment)	Fusion Rate (%)(as determined by CT assessment)	6 months post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic outcome assessments	Radiographic outcome assessments	Pre-operatively, 6 weeks, 3, 6, 12 and 24 months
Functional outcome measurements	FFI-R, SF-12	Pre-operatively, 6 weeks, 3, 6, 12 and 24 months
Functional outcome measurements	AOFAS	Pre-operatively, 3, 6, 12 and 24 months

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2010
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: August 8, 2011
• First Submitted That Met QC Criteria: August 9, 2011
• First Posted (Estimate): August 10, 2011

Study Record Updates

• Last Update Posted (Actual): April 13, 2018
• Last Update Submitted That Met QC Criteria: April 11, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Post-traumatic Arthritis; Other Hindfoot Conditions requiring Subtalar Arthrodesis
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Osteoarthritis
• Other Study ID Numbers: AlloSource Subtalar Fusion RCT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No