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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis of First Metatarsalphalangeal Joint Arthritis Foot Deformities Foot Deformities, Acquired Foot Injuries Hallux Limitus Hallux Rigidus Joint Diseases Leg Injuries Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Calgary, Calgary, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Arthrodesis

Device

arthrodesis using screws and/or a plate

Cartiva

Device

Cartiva Synthetic Cartilage Implant

Primary outcomes

VAS, FAAM, Safety

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cartiva, Inc.

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2016
Study completion: 2016
First posted: Sep 2, 2009
Registry last updated: Nov 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed