This trial is active, not recruiting.

Condition osteoarthritis of first metatarsalphalangeal joint
Treatments arthrodesis, cartiva
Phase phase 3
Sponsor Cartiva, Inc.
Start date August 2009
End date February 2019
Trial size 236 participants
Trial identifier NCT00969969, PTC-0031


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
arthrodesis using screws and/or a plate
Synthetic Cartilage Implant
Cartiva Synthetic Cartilage Implant

Primary Outcomes

VAS, FAAM, Safety
time frame: up to 7 years

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title A Study to Evaluate the Effectiveness and Safety of an Implant in the Treatment of Osteoarthritis of the Great Toe
Principal investigator Judith Baumhauer
Description Evaluate and confirm long-term the safety and effectiveness of the Cartiva SCI implant established by the pivotal trial.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Cartiva, Inc..