NCT02391506

Brief Summary

This study will evaluate whether Cartiva is an effective treatment for individuals with osteoarthritis of the CMC joint in the hand.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
2 countries

9 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

First Submitted

Initial submission to the registry

March 9, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

July 29, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2019

Completed
Last Updated

March 22, 2019

Status Verified

March 1, 2019

Enrollment Period

3.6 years

First QC Date

March 9, 2015

Last Update Submit

March 20, 2019

Conditions

Osteoarthritis

Keywords

First CMC jointOsteoarthritisCartilage ReplacementFirst CMC Joint OsteoarthritisDamaged Articular Surface

Outcome Measures

Primary Outcomes (1)

  • Pain measured by the Visual Analog Scale (VAS) scale

    1 year follow up

Study Arms (1)

Cartiva

EXPERIMENTAL

Synthetic Cartilage Implant

Device: Cartiva

Interventions

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 carpometacarpal joint
  • Presence of good bone stock without the need for bone graft
  • Capable of completing self-administered questionnaires

You may not qualify if:

  • \< 18 years of age
  • Active bacterial infection of the hand
  • Previous CMC implant and/or surgery to the affected joint to be treated that would prevent implantation and fixation of Cartiva® SCI for CMC
  • Patient has osteoarthritis of the scaphotrapeziotrapezoidal (STT) joint in the hand to be treated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University of Calgary

Calgary, Alberta, Canada

Location

UBC, Division of Plastic Surgery

Vancouver, British Columbia, V5Z1M9, Canada

Location

QEII Health Sciences Center

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

Woodend Hospital

Aberdeen, Scotland, AB15 6XS, United Kingdom

Location

Royal United Hospital

Bath, BA1 3NG, United Kingdom

Location

Royal Derby Hospital

Derby, DE22 3NE, United Kingdom

Location

South Tees Hospital

Middlesbrough, TS 4 3BW, United Kingdom

Location

Queen Alexandra Hospital

Portsmouth, PO6 3LY, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2015

First Posted

March 18, 2015

Study Start

July 29, 2015

Primary Completion

March 5, 2019

Study Completion

March 5, 2019

Last Updated

March 22, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(5)CA(4)