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Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft

Primary Purpose

Degenerative Osteoarthritis, Post-traumatic; Arthrosis, Rheumatoid Arthritis & Other Inflammatory Polyarthropathies

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Subtalar Arthrodesis

About this trial

This is an interventional treatment trial for Degenerative Osteoarthritis focused on measuring Other Hindfoot Conditions requiring Subtalar Arthrodesis, Post-traumatic Arthritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.
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.

Sites / Locations

Institute for Foot and Ankle Reconstruction at Mercy
Orthopaedic Associates of Michigan
Minnesota Orthopedic Sports Medicine Institute (MOSMI)
Penn State Milton S. Hershey Medical Center
Campbell Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

AlloStem Live Cellular Allograft

Control: Autologous Bone Marrow Aspirate

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Radiographic outcome assessments

Functional outcome measurements

FFI-R, SF-12

Functional outcome measurements

AOFAS

Full Information

NCT ID

NCT01413061

First Posted

August 8, 2011

Last Updated

April 11, 2018

Sponsor

AlloSource

1. Study Identification

Unique Protocol Identification Number

NCT01413061

Brief Title

Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft

Official Title

Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

June 2010 (Actual)

Primary Completion Date

February 2017 (Actual)

Study Completion Date

March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AlloSource

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AlloStem Live Cellular Allograft

Arm Type

Active Comparator

Arm Description

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

Arm Title

Control: Autologous Bone Marrow Aspirate

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Subtalar Arthrodesis

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

6 months post-op

Secondary Outcome Measure Information:

Title

Radiographic outcome assessments

Description

Radiographic outcome assessments

Time Frame

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

Title

Functional outcome measurements

Description

FFI-R, SF-12

Time Frame

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

Title

Functional outcome measurements

Description

AOFAS

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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. 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.

Overall Study Officials: