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

Cartiva

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis of First Metatarsalphalangeal Joint

Treatments: Device: Cartiva; Device: Arthrodesis

Study type: Interventional

Funder types: Industry

Identifiers

NCT00969969

PTC-0031

Details and patient eligibility

About

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

Enrollment: 236 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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236 participants in 2 patient groups

Arthrodesis

Active Comparator group

Description:

Fusion

Treatment:

Device: Arthrodesis

Cartiva

Experimental group

Description:

Synthetic Cartilage Implant

Treatment:

Device: Cartiva