NCT01133197

Brief Summary

This study is designed to define the impact of thumb arthritis on patient's general health. As a secondary objective, data will be analyzed to determine the effects of medical and musculoskeletal comorbidities on the rating of upper extremity function by the patient.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
188

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

July 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 28, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 29, 2015

Status Verified

June 1, 2015

Enrollment Period

5.9 years

First QC Date

May 26, 2010

Last Update Submit

June 26, 2015

Conditions

Thumb Arthritis

Keywords

thumbarthritisImpact of thumb arthritis on health

Outcome Measures

Primary Outcomes (1)

  • Hand Function

    Use of hand by Michigan Hand Questionnaire

    Baseline

Secondary Outcomes (1)

  • Overall Health

    Baseline

Study Arms (2)

controls

No hand arthritis

CMC Arthritis

Patients with arthritis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients presenting for treatment have thumb arthritis

You may qualify if:

  • Healthy adults clinically diagnosed with thumb carpometacarpal osteoarthritis. The diagnosis must have been confirmed radiographically prior to consideration for study enrollment.
  • Adults accompanying patients to participating offices will be recruited to be control subjects. They must not be receiving medical or surgical treatment for a hand or wrist complaint.
  • Additionally control subjects must not have been diagnosed with thumb osteoarthritis.

You may not qualify if:

  • Subjects must be over 18 years of age and English speaking.
  • Subjects are not to include incarcerated adults or those unable to provide consent for study participation.
  • Patients diagnosed with currently symptomatic hand or wrist pathology outside of the thumb carpometacarpal joint will be excluded.
  • Patient with prior surgery on the affected thumb will be excluded.
  • Pregnant females are excluded from study participation with pregnancy determined by patient self-reporting (standard of care before office radiographs).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Ryan P Calfee, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Orthopaedic Surgery

Study Record Dates

First Submitted

May 26, 2010

First Posted

May 28, 2010

Study Start

July 1, 2009

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 29, 2015

Record last verified: 2015-06

Locations

US(1)