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

Phase 3

Completed

• Conditions: Osteoarthritis of First Metatarsalphalangeal Joint
• Interventions: Device: Cartiva; Device: Arthrodesis

• Registration Number: NCT00969969
• Lead Sponsor: Cartiva, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-09-01
• Study First Submitted QC: 2009-09-01
• Study First Posted: 2009-09-02
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-10
• Last Update Posted: 2016-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cartiva	Cartiva	Synthetic Cartilage Implant
Arthrodesis	Arthrodesis	Fusion

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (12)

Northern General Hospital NHS Trusts - Sheffield Orthopaedics; 🇬🇧 Sheffield, South Yorkshire, United Kingdom

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

St. George's Hospital; 🇬🇧 Tooting, London, United Kingdom

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

University of Calgary; 🇨🇦 Calgary, Alberta, Canada

Frimley Park Hospital - Surrey Foot and Ankle Clinic; 🇬🇧 Frimley, Camberley, United Kingdom

Torbay Hospital; 🇬🇧 South Devon, Torquay, United Kingdom

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Royal National Orthopaedic Hospital - Stanmore Foot & Ankle Clinic; 🇬🇧 Stanmore, Middlesex, United Kingdom

Royal Surrey County Hospital; 🇬🇧 Guildford, Surrey, United Kingdom

Queen Elizabeth Science Centre; 🇨🇦 Halifax, Nova Scotia, Canada

Horizon Health Network; 🇨🇦 Fredericton, New Brunswick, Canada