NCT00969969

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2009

Longer than P75 for phase_3

Geographic Reach
2 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2009

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

November 15, 2016

Status Verified

November 1, 2016

Enrollment Period

6.9 years

First QC Date

September 1, 2009

Last Update Submit

November 10, 2016

Conditions

Osteoarthritis of First Metatarsalphalangeal Joint

Keywords

First MTP JointHallux RigidusHallux LimitusCartilage ReplacementOsteoarthritisFirst MTP Joint OsteoarthritisBig Toe Pain

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Arthrodesis

ACTIVE COMPARATOR

Fusion

Device: Arthrodesis

Cartiva

EXPERIMENTAL

Synthetic Cartilage Implant

Device: Cartiva

Interventions

ArthrodesisDEVICE

arthrodesis using screws and/or a plate

Arthrodesis
CartivaDEVICE

Cartiva Synthetic Cartilage Implant

Cartiva

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • \< 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

University of Alberta

Edmonton, Alberta, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Horizon Health Network

Fredericton, New Brunswick, E3B 5N5, Canada

Location

Queen Elizabeth Science Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5C 1R6, Canada

Location

Frimley Park Hospital - Surrey Foot and Ankle Clinic

Frimley, Camberley, GU16 7UJ, United Kingdom

Location

St. George's Hospital

Tooting, London, SW17 0QT, United Kingdom

Location

Royal National Orthopaedic Hospital - Stanmore Foot & Ankle Clinic

Stanmore, Middlesex, HA7 4LP, United Kingdom

Location

Northern General Hospital NHS Trusts - Sheffield Orthopaedics

Sheffield, South Yorkshire, S5 7AU, United Kingdom

Location

Royal Surrey County Hospital

Guildford, Surrey, GU2 5XX, United Kingdom

Location

Torbay Hospital

South Devon, Torquay, TQ2 7AA, United Kingdom

Location

MeSH Terms

Conditions

Hallux RigidusHallux LimitusOsteoarthritis

Interventions

Arthrodesis

Condition Hierarchy (Ancestors)

Foot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesJoint DiseasesFoot InjuriesLeg InjuriesWounds and InjuriesArthritisRheumatic Diseases

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresSurgical Procedures, Operative

Study Officials

  • Judith Baumhauer

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2009

First Posted

September 2, 2009

Study Start

August 1, 2009

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

November 15, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(6)GB(6)