Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft

NCT01413061 | Completed

• 1 other identifier: AlloSource Subtalar Fusion RCT
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Keywords

Other Hindfoot Conditions requiring Subtalar Arthrodesis; Post-traumatic Arthritis

Outcome Measures

Primary Outcomes (1)

• Fusion Rate (%)(as determined by CT assessment)

  Fusion Rate (%)(as determined by CT assessment)

  6 months post-op

Secondary Outcomes (3)

• Radiographic outcome assessments

  Pre-operatively, 6 weeks, 3, 6, 12 and 24 months

• Functional outcome measurements

  Pre-operatively, 6 weeks, 3, 6, 12 and 24 months

• Functional outcome measurements

  Pre-operatively, 3, 6, 12 and 24 months

Study Arms (2)

AlloStem Live Cellular Allograft

ACTIVE COMPARATOR

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

Procedure: Subtalar Arthrodesis

Control: Autologous Bone Marrow Aspirate

ACTIVE COMPARATOR

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

Procedure: Subtalar Arthrodesis

Interventions

Subtalar Arthrodesis PROCEDURE

AlloStem Live Cellular Allograft; Control: Autologous Bone Marrow Aspirate

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be diagnosed with degenerative osteoarthritis, post-traumatic arthritis, inflammatory arthritis (ie: rheumatoid arthritis) or other conditions of the hindfoot requiring subtalar arthrodesis.
• Patients must be able to attend follow-up examinations for the duration of the trial.
• The patient is at least 18 years of age and skeletally mature, or less than 80 years of age at the time of surgery.
• Is willing and able to comply with the clinical trial plan and able to understand and sign the Patient Informed Consent Form.

You may not qualify if:

• Younger than 18 years old or older than 80 years old.
• Has a condition that prevents ambulation or completion of any of the trial measurements.
• Has treatment planned for the arthrodesis which does not require the use of screws.
• Has any active infection of the hindfoot, a systemic infection or bacteremia.
• Has received any treatment within the past 12 months which may interfere with bone metabolism \[bisphosphonates (Fosamax, Actonel, Boniva, Reclast) and calcitonin (Miacalcin)\].
• Is scheduled to have any surgical procedure on the contralateral foot within 6 weeks before or after the study procedure.

Sponsors & Collaborators

• AlloSource: lead

Study Sites (5)

Institute for Foot and Ankle Reconstruction at Mercy

Baltimore, Maryland, 21202, United States

Location

Orthopaedic Associates of Michigan

Grand Rapids, Michigan, 49525, United States

Location

Minnesota Orthopedic Sports Medicine Institute (MOSMI)

Edina, Minnesota, 55435, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Campbell Clinic

Germantown, Tennessee, 38138, United States

Location

MeSH Terms

Conditions

Joint Diseases; Osteoarthritis; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Arthritis; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2011
• First Posted: August 10, 2011
• Study Start: June 1, 2010
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2018
• Last Updated: April 13, 2018

Record last verified: 2018-04

Locations

US (5)