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A Study to Evaluate the Effectiveness and Safety of an Implant in the Treatment of Osteoarthritis of the Great Toe

NCT00969969 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2016-11-15

No results posted yet for this study

Summary

This study will evaluate whether Cartiva is an effective treatment for individuals with osteoarthritis of the great toe.

Conditions

  • Osteoarthritis of First Metatarsalphalangeal Joint

Interventions

DEVICE

Arthrodesis

arthrodesis using screws and/or a plate

DEVICE

Cartiva

Cartiva Synthetic Cartilage Implant

Sponsors & Collaborators

  • Cartiva, Inc.

    lead INDUSTRY

Principal Investigators

  • Judith Baumhauer · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • Canada
  • United Kingdom

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 NCT00969969 on ClinicalTrials.gov