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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Carticept Medical, Inc
ClinicalTrials.gov Identifier:
NCT00969969
First received: September 1, 2009
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
First MTP Joint Osteoarthritis
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 Carticept Medical, Inc:

Primary Outcome Measures:
  • VAS, FAAM, Safety [ Time Frame: Preop, 2 week, 6 week, 3 month, 6 month, 1 year and 2 year follow ups ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 230
Study Start Date: August 2009
Estimated Primary Completion Date: January 2015 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969969

Locations
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
Carticept Medical, Inc
  More Information

No publications provided

Responsible Party: Carticept Medical, Inc
ClinicalTrials.gov Identifier: NCT00969969     History of Changes
Other Study ID Numbers: PTC-0031
Study First Received: September 1, 2009
Last Updated: February 17, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
United Kingdom: National Health Service

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

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 16, 2014