A Study to Evaluate the Effectiveness and Safety of an Implant in the Treatment of Osteoarthritis of the Great Toe
NCT ID: NCT00969969
Last Updated: 2016-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
236 participants
INTERVENTIONAL
2009-08-31
2016-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arthrodesis
Fusion
Arthrodesis
arthrodesis using screws and/or a plate
Cartiva
Synthetic Cartilage Implant
Cartiva
Cartiva Synthetic Cartilage Implant
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Arthrodesis
arthrodesis using screws and/or a plate
Cartiva
Cartiva Synthetic Cartilage Implant
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cartiva, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Judith Baumhauer
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Calgary
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Horizon Health Network
Fredericton, New Brunswick, Canada
Queen Elizabeth Science Centre
Halifax, Nova Scotia, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Frimley Park Hospital - Surrey Foot and Ankle Clinic
Frimley, Camberley, United Kingdom
St. George's Hospital
Tooting, London, United Kingdom
Royal National Orthopaedic Hospital - Stanmore Foot & Ankle Clinic
Stanmore, Middlesex, United Kingdom
Northern General Hospital NHS Trusts - Sheffield Orthopaedics
Sheffield, South Yorkshire, United Kingdom
Royal Surrey County Hospital
Guildford, Surrey, United Kingdom
Torbay Hospital
South Devon, Torquay, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PTC-0031
Identifier Type: -
Identifier Source: org_study_id