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

This study has been completed.
Information provided by (Responsible Party):
Cartiva, Inc. Identifier:
First received: September 1, 2009
Last updated: November 10, 2016
Last verified: November 2016
This study will evaluate whether Cartiva is an effective treatment for individuals with osteoarthritis of the great toe.

Condition Intervention Phase
Osteoarthritis of First Metatarsalphalangeal Joint
Device: Arthrodesis
Device: Cartiva
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Effectiveness and Safety of an Implant in the Treatment of Osteoarthritis of the Great Toe

Resource links provided by NLM:

Further study details as provided by Cartiva, Inc.:

Primary Outcome Measures:
  • 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.

Enrollment: 236
Study Start Date: August 2009
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arthrodesis
Device: Arthrodesis
arthrodesis using screws and/or a plate
Experimental: Cartiva
Synthetic Cartilage Implant
Device: Cartiva
Cartiva Synthetic Cartilage Implant


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00969969

Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 4N1
University of Alberta
Edmonton, Alberta, Canada
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, New Brunswick
Horizon Health Network
Fredericton, New Brunswick, Canada, E3B 5N5
Canada, Nova Scotia
Queen Elizabeth Science Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5C 1R6
United Kingdom
Frimley Park Hospital - Surrey Foot and Ankle Clinic
Frimley, Camberley, United Kingdom, GU16 7UJ
St. George's Hospital
Tooting, London, United Kingdom, SW17 0QT
Royal National Orthopaedic Hospital - Stanmore Foot & Ankle Clinic
Stanmore, Middlesex, United Kingdom, HA7 4LP
Northern General Hospital NHS Trusts - Sheffield Orthopaedics
Sheffield, South Yorkshire, United Kingdom, S5 7AU
Royal Surrey County Hospital
Guildford, Surrey, United Kingdom, GU2 5XX
Torbay Hospital
South Devon, Torquay, United Kingdom, TQ2 7AA
Sponsors and Collaborators
Cartiva, Inc.
Principal Investigator: Judith Baumhauer University of Rochester
  More Information

Responsible Party: Cartiva, Inc. Identifier: NCT00969969     History of Changes
Other Study ID Numbers: PTC-0031
Study First Received: September 1, 2009
Last Updated: November 10, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Cartiva, Inc.:
First MTP Joint
Hallux Rigidus
Hallux Limitus
Cartilage Replacement
First MTP Joint Osteoarthritis
Big Toe Pain

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on May 23, 2017