Trial Outcomes & Findings for Factors Associated With Radiographic Pathophysiology for Trapeziometacarpal Arthrosis in Patients Not Seeking Care for This Condition (NCT NCT02252939)

Last Updated: 2019-08-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

62 participants

Primary outcome timeframe

Baseline at Day 1

Results posted on

2019-08-14

Participant Flow

Participant milestones

Participant milestones
Measure	Patients With Trapeziometacarpal (TMC) Arthrosis Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis X-Ray: X-ray as part of standard care
Overall Study STARTED	62
Overall Study COMPLETED	59
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients With Trapeziometacarpal (TMC) Arthrosis Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis X-Ray: X-ray as part of standard care
Overall Study Lost to Follow-up	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Trapeziometacarpal (TMC) Arthrosis n=59 Participants Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis X-Ray: X-ray as part of standard care
Age, Continuous	67 Years n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	56 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	59 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline at Day 1

Population: Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis X-Ray: X-ray as part of standard care

Outcome measures

Outcome measures
Measure	Patients With Trapeziometacarpal Arthrosis Eaton Stage I n=5 Participants Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis, Eaton Stage I X-Ray: X-ray as part of standard care	Patients With Trapeziometacarpal Arthrosis Eaton Stage II n=36 Participants Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis, Eaton Stage II X-Ray: X-ray as part of standard care	Patients With Trapeziometacarpal Arthrosis Eaton Stage III-IV n=18 Participants Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis, Eaton Stage III-IV X-Ray: X-ray as part of standard care
Factors Associated With Eaton Classification of Trapeziometacarpal Arthrosis: Age	61 Years Interval 56.0 to 66.0	66 Years Interval 62.0 to 70.0	75 Years Interval 66.0 to 82.0

SECONDARY outcome

Timeframe: Day 1, baseline

Population: All patients with TMC Arthrosis analyzed for hyperextension of MCP joint.

Thumb pain measured on a scale of 0-10 and dichotomized by having thumb pain (yes/no), hyperextension dichotomized (yes/no)

Outcome measures

Outcome measures
Measure	Patients With Trapeziometacarpal Arthrosis Eaton Stage I n=11 Participants Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis, Eaton Stage I X-Ray: X-ray as part of standard care	Patients With Trapeziometacarpal Arthrosis Eaton Stage II n=48 Participants Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis, Eaton Stage II X-Ray: X-ray as part of standard care	Patients With Trapeziometacarpal Arthrosis Eaton Stage III-IV Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis, Eaton Stage III-IV X-Ray: X-ray as part of standard care
Factors Associated With Thumb Pain: Hyperextension of Metacarpophalangeal Joint	10 Participants	26 Participants	—

SECONDARY outcome

Timeframe: Day 1, baseline

Population: Data were not collected

Outcome measures

Outcome data not reported

Adverse Events

Patients With Trapeziometacarpal (TMC) Arthrosis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rachel Gottlieb, Research Coordinator

Massachusetts General Hospital

Phone: 617-726-1569

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place