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Completed

NCT Number: NCT02978573

Post Approval Study to Evaluate the Effectiveness and Safety of Cartiva Implant in the Treatment of OA of the Great Toe

Evaluate and confirm the long-term safety and effectiveness of the Cartiva SCI implant established by the pivotal trial.

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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

About this study

As part of the Conditions of Approval of Cartiva SCI for the treatment of first MTP osteoarthritis, the Food and Drug Administration (FDA) requires additional long term data to evaluate the long term safety and effectiveness of Cartiva including the durability and survivorship of the implant. This Post-Approval Study (PAS) addendum is intended to supplement the initial 24 months follow up period and provide additional long term safety and effectiveness data on Cartiva

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject must have been treated with Cartiva under MOTION study protocol PTC-0031; and,
  • Have been informed of the nature of the study, agreeing to its requirements, and have signed the informed consent approved by the IRB/Ethics Committee for long-term follow-up.

Exclusion criteria

  • Subjects who underwent a secondary surgical intervention to have the Cartiva implant removed during the 24-month time period of participation in the MOTION study.

Treatment and study plan

Cartiva

Device

Cartiva Synthetic Cartilage Implant

Primary outcomes

  1. Long Term Safety of the Cartiva Implant by demonstrating durability over the long term and no unanticipated safety concerns that arise

    Time frame: 5 year

    • Durability of the implant over the longer term. This will be addressed using survival analysis starting at Month 24 to determine the rate of implant removals among devices that survived to Month 24. A complementary survival analysis starting at index surgery to end of study will also be performed.
    • There are no unanticipated safety concerns that arise after Month 24 up to 5 years. This will be addressed by a) determining the incidence of serious device-related adverse events per year and overall from Month 24 to Year 5; and b) summarizing device-related radiographic complications1 over time from Month 24 to Year 5. Note that this analysis will address both device and procedure related complications and serious device-related adverse events whether observed previously in the 24 month follow up portion of the study or encountered for this first time during the extended follow-up period.

Secondary outcomes

  1. Pain Scale (VAS)

    Time frame: 5 year

    Visual Analog Scale (VAS) Pain

  2. Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL)

    Time frame: 5 year

    Foot and Ankle Ability Measure (FAAM) Activities of Daily Living scores

  3. Foot and Ankle Ability Measure (FAAM) Sports

    Time frame: 5 year

    Foot and Ankle Ability Measure (FAAM) Sports scores

Sponsors and collaborators

Lead sponsor

Cartiva, Inc.

Industry

Registry information

Official study title

A Post Approval Study to Evaluate the Safety and Effectiveness of Cartiva Implant in the Treatment of First Metatarsophalangeal Joint Osteoarthritis as Compared to a Control

Acronym: MOTION

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 1, 2016
Registry last updated
Mar 22, 2019

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.

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