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Factors Associated With Radiographic Pathophysiology for Trapeziometacarpal Arthrosis in Patients Not Seeking Care for This Condition

Primary Purpose

Trapeziometacarpal Arthrosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
X-Ray
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trapeziometacarpal Arthrosis

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 55 years and older
  • Not seeking care for TMC arthrosis from hand surgeon at the time of visit
  • english fluency and literacy

Exclusion Criteria:

-

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with Trapeziometacarpal (TMC) Arthrosis

Arm Description

Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis

Outcomes

Primary Outcome Measures

Factors Associated With Eaton Classification of Trapeziometacarpal Arthrosis: Age
Radiographs were scored using the Eaton score range.The Eaton score ranges from 1-4 where 1 is the least severe and 4 is the most severe for arthritis. Patients without TMC Arthritis would have a score of 0. Patients' age measured in years.

Secondary Outcome Measures

Factors Associated With Thumb Pain: Hyperextension of Metacarpophalangeal Joint
Thumb pain measured on a scale of 0-10 and dichotomized by having thumb pain (yes/no), hyperextension dichotomized (yes/no)
QuickDASH (Disability of the Arm, Shoulder, and Hand)

Full Information

First Posted
August 12, 2014
Last Updated
August 13, 2019
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02252939
Brief Title
Factors Associated With Radiographic Pathophysiology for Trapeziometacarpal Arthrosis in Patients Not Seeking Care for This Condition
Official Title
Factors Associated With Radiographic Pathophysiology for Trapeziometacarpal Arthrosis in Patients Not Seeking Care for This Condition
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators are doing this research study to discover factors, such as job, hobbies, or race that are associated with arthrosis at the base of your thumb on X-rays. Thumb arthrosis is one of the most common kinds of arthritis. About 116 people will take part in this research study at Massachusetts General Hospital (MGH).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trapeziometacarpal Arthrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with Trapeziometacarpal (TMC) Arthrosis
Arm Type
Experimental
Arm Description
Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis
Intervention Type
Radiation
Intervention Name(s)
X-Ray
Intervention Description
X-ray as part of standard care
Primary Outcome Measure Information:
Title
Factors Associated With Eaton Classification of Trapeziometacarpal Arthrosis: Age
Description
Radiographs were scored using the Eaton score range.The Eaton score ranges from 1-4 where 1 is the least severe and 4 is the most severe for arthritis. Patients without TMC Arthritis would have a score of 0. Patients' age measured in years.
Time Frame
Baseline at Day 1
Secondary Outcome Measure Information:
Title
Factors Associated With Thumb Pain: Hyperextension of Metacarpophalangeal Joint
Description
Thumb pain measured on a scale of 0-10 and dichotomized by having thumb pain (yes/no), hyperextension dichotomized (yes/no)
Time Frame
Day 1, baseline
Title
QuickDASH (Disability of the Arm, Shoulder, and Hand)
Time Frame
Day 1, baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 55 years and older Not seeking care for TMC arthrosis from hand surgeon at the time of visit english fluency and literacy Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal Chen, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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Factors Associated With Radiographic Pathophysiology for Trapeziometacarpal Arthrosis in Patients Not Seeking Care for This Condition

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