Osteoarthritis of First Metatarsalphalangeal Joint
Conditions
Keywords
First MTP Joint, Hallux Rigidus, Hallux Limitus, Cartilage Replacement, Osteoarthritis, First MTP Joint Osteoarthritis, Big Toe Pain
Brief summary
This study will evaluate whether Cartiva is an effective treatment for individuals with osteoarthritis of the great toe.
Interventions
DEVICEArthrodesis
arthrodesis using screws and/or a plate
DEVICECartiva
Cartiva Synthetic Cartilage Implant
Sponsors
Cartiva, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS, FAAM, Safety | 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. |
Countries
Canada, United Kingdom
Outcome results
None listed