Status:
COMPLETED
A Study to Evaluate the Effectiveness and Safety of an Implant in the Treatment of Osteoarthritis of the Great Toe
Lead Sponsor:
Cartiva, Inc.
Conditions:
Osteoarthritis of First Metatarsalphalangeal Joint
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will evaluate whether Cartiva is an effective treatment for individuals with osteoarthritis of the great toe.
Eligibility Criteria
Inclusion
- ≥ 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
- \< 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)
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT00969969
Start Date
August 1 2009
End Date
July 1 2016
Last Update
November 15 2016
Active Locations (12)
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1
University of Calgary
Calgary, Alberta, Canada, T2N 4N1
2
University of Alberta
Edmonton, Alberta, Canada
3
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
4
Horizon Health Network
Fredericton, New Brunswick, Canada, E3B 5N5