NCT06142370

Brief Summary

The purpose of this study is to explore the physical exam characteristics of patients referred to orthopedic surgeons with a diagnosis of thumb carpometacarpal (CMC) arthritis. CMC osteoarthritis of the thumb is one of the most common degenerative conditions of the hand in 11% of men and 33% of women (Gillis et al., 2011). Patients with CMC arthritis may experience pain, decreased range of motion, loss of grip and pinch strength, often limiting participation in activities of daily living (Bertozzi et al., 2014). In 1979, two physicians identified a variation of a tendinous connection in the wrist between the tip of the index finger and the tip of the thumb known as the Linburg-Comstock variation (LCV) (Linburg \& Comstock, 1979). The prevalence of the LCV varies respectively from 13-66% in both males and females (Erić et al., 2019). A physical examination of patients with LCV reveals concurrent flexion of the flexor digitorum profundus to the index finger and flexor pollicis longus. The study aims to gain more insight into patients diagnosed with CMC arthritis through clinical examination for LCV to consider an association of the diagnoses. Currently, there is no evidence surrounding patients with symptomatic CMC arthritis and LCV. The hypothesis is that there is an association between symptomatic CMC arthritis and LCV. Patients with a LCV may then be more likely to develop painful CMC arthritis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 7, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2025

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

November 16, 2023

Last Update Submit

November 16, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • LCV

    A positive or negative clinical exam

    10 seconds

Study Arms (1)

Positive LCV

OTHER

A patient who tests positive by clinical exam of a LCV.

Other: Descriptive

Interventions

The patients will be asked by the recruiting physicians to perform a clinical examination looking for the LCV, which will take a total of five seconds. This is a self-test and not part of a regular clinical examination

Positive LCV

Eligibility Criteria

Age35 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female
  • Over the age of 35
  • Under the age of 89
  • Diagnosis of thumb CMC arthritis, ICD-10 code M19.12
  • Initial non-surgical intervention for thumb CMC arthritis

You may not qualify if:

  • Under the age of 35
  • Over the age of 89
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Bone and Joint Center

Albany, New York, 12204, United States

Location

MeSH Terms

Conditions

Hand Deformities

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

  • Chris Mulligan

    Russell Sage College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 16, 2023

First Posted

November 21, 2023

Study Start

May 7, 2022

Primary Completion

May 10, 2024

Study Completion

May 10, 2025

Last Updated

November 21, 2023

Record last verified: 2023-11

Locations