Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft

Not Applicable

Completed

• Conditions: Degenerative Osteoarthritis; Rheumatoid Arthritis & Other Inflammatory Polyarthropathies; Rheumatoid Arthritis of Subtalar Joint; Post-traumatic; Arthrosis
• Interventions: Procedure: Subtalar Arthrodesis

• Registration Number: NCT01413061
• Lead Sponsor: AlloSource

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2011-08-08
• Study First Submitted QC: 2011-08-09
• Study First Posted: 2011-08-10
• Primary Completion: 2017-02
• Study Completion: 2018-03
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-11
• Last Update Posted: 2018-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AlloStem Live Cellular Allograft	Subtalar Arthrodesis	AlloStem is the combination of the Mesenchymal Stem Cells (MSC) derived from adipose with demineralized bone.
Control: Autologous Bone Marrow Aspirate	Subtalar Arthrodesis	Autologous bone graft is recovered from the patient's own tibia or iliac crest, for transplantation in the subtalar joint.

Primary Outcome Measures

Name	Time	Method
Fusion Rate (%)(as determined by CT assessment)	6 months post-op	Fusion Rate (%)(as determined by CT assessment)

Secondary Outcome Measures

Name	Time	Method
Functional outcome measurements	Pre-operatively, 3, 6, 12 and 24 months	AOFAS
Radiographic outcome assessments	Pre-operatively, 6 weeks, 3, 6, 12 and 24 months	Radiographic outcome assessments

Trial Locations

Locations (5)

Orthopaedic Associates of Michigan; 🇺🇸 Grand Rapids, Michigan, United States

Minnesota Orthopedic Sports Medicine Institute (MOSMI); 🇺🇸 Edina, Minnesota, United States

Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States

Campbell Clinic; 🇺🇸 Germantown, Tennessee, United States

Institute for Foot and Ankle Reconstruction at Mercy; 🇺🇸 Baltimore, Maryland, United States