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Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft

NCT01413061 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2018-04-13

No results posted yet for this study

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

Interventions

PROCEDURE

Subtalar Arthrodesis

Sponsors & Collaborators

  • AlloSource

    lead INDUSTRY

Principal Investigators

  • Christiaan Coetzee, MD · Minnesota Orthopedic Sports Medicine Institute (MOSMI)

  • Mark Myerson, MD · Institute for Foot and Ankle Reconstruction at Mercy

  • John Anderson, MD · Orthopaedic Associates of Michigan

  • Paul Juliano, MD · Milton S. Hershey Medical Center

  • Andrew Murphy, MD · Campbell Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2017-02-28
Completion
2018-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01413061 on ClinicalTrials.gov