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

November 10, 2016 updated by: Cartiva, Inc.
This study will evaluate whether Cartiva is an effective treatment for individuals with osteoarthritis of the great toe.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

236

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • University of Calgary
      • Edmonton, Alberta, Canada
        • University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 5N5
        • Horizon Health Network
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Queen Elizabeth Science Centre
    • Ontario
      • Toronto, Ontario, Canada, M5C 1R6
        • St. Michael's Hospital
  • United Kingdom
    • Camberley
      • Frimley, Camberley, United Kingdom, GU16 7UJ
        • Frimley Park Hospital - Surrey Foot and Ankle Clinic
    • London
      • Tooting, London, United Kingdom, SW17 0QT
        • St. George's Hospital
    • Middlesex
      • Stanmore, Middlesex, United Kingdom, HA7 4LP
        • Royal National Orthopaedic Hospital - Stanmore Foot & Ankle Clinic
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S5 7AU
        • Northern General Hospital NHS Trusts - Sheffield Orthopaedics
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 5XX
        • Royal Surrey County Hospital
    • Torquay
      • South Devon, Torquay, United Kingdom, TQ2 7AA
        • Torbay Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥ 18 years of age
  • Osteoarthritis of the first metatarsophalangeal joint and is a candidate for arthrodesis
  • Presence of good bone stock
  • Capable of completing self-administered questionnaires

Exclusion Criteria:

  • < 18 years of age
  • Osteoarthritis of the first metatarsophalangeal joint, though is not a candidate for arthrodesis
  • Active bacterial infection of the foot
  • Additional ipsilateral limb (hip, knee, ankle, or foot) pathology that requires active treatment (surgery or brace)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Arthrodesis
Fusion
Device: Arthrodesis
arthrodesis using screws and/or a plate
EXPERIMENTAL: Cartiva
Synthetic Cartilage Implant
Device: Cartiva
Cartiva Synthetic Cartilage Implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS, FAAM, Safety
Time Frame: up to 2 years
The individual components of the primary outcome measures will be Visual Analog Scale (VAS) Pain, Foot and Ankle Ability Measure (FAAM) Sports sub-scale score and absence of key safety issues.
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cartiva, Inc.

Investigators

  • Principal Investigator: Judith Baumhauer, University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ACTUAL)

July 1, 2016

Study Completion (ACTUAL)

July 1, 2016

Study Registration Dates

First Submitted

September 1, 2009

First Submitted That Met QC Criteria

September 1, 2009

First Posted (ESTIMATE)

September 2, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 15, 2016

Last Update Submitted That Met QC Criteria

November 10, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTC-0031

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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