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

Osteoarthritis of First Metatarsalphalangeal Joint Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00969969
• Other study ID #: PTC-0031
• Status: Completed
• Phase: Phase 3
• First received: September 1, 2009
• Last updated: November 10, 2016
• Start date: August 2009
• Est. completion date: July 2016

Study information

• Verified date: November 2016
• Source: Cartiva, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaUnited Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of First Metatarsalphalangeal Joint

Intervention

Device:
• Arthrodesis
arthrodesis using screws and/or a plate
• Cartiva
Cartiva Synthetic Cartilage Implant

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	Horizon Health Network	Fredericton	New Brunswick
Canada	Queen Elizabeth Science Centre	Halifax	Nova Scotia
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
United Kingdom	Frimley Park Hospital - Surrey Foot and Ankle Clinic	Frimley	Camberley
United Kingdom	Royal Surrey County Hospital	Guildford	Surrey
United Kingdom	Northern General Hospital NHS Trusts - Sheffield Orthopaedics	Sheffield	South Yorkshire
United Kingdom	Torbay Hospital	South Devon	Torquay
United Kingdom	Royal National Orthopaedic Hospital - Stanmore Foot & Ankle Clinic	Stanmore	Middlesex
United Kingdom	St. George's Hospital	Tooting	London

Sponsors (1)

Lead Sponsor	Collaborator
Cartiva, Inc.

Countries where clinical trial is conducted

Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS, FAAM, Safety	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.	up to 2 years	Yes