Tendon Variation Study for Hand Anomalies

(LCV Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Russell Sage College

Disqualifiers: Under 35, Over 89, Prisoners

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

500 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Chris Mulligan

Principal Investigator

Russell Sage College

Eligibility Criteria

This trial is for men and women aged 35 to 89 who have been diagnosed with thumb carpometacarpal (CMC) arthritis and have tried non-surgical treatments. It's not open to individuals under 35, over 89, or prisoners.

Inclusion Criteria

I have been diagnosed with thumb arthritis.

I am either male or female.

I am younger than 89 years old.

Exclusion Criteria

Prisoners

I am younger than 35 years old.

I am 90 years old or older.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Clinical Examination

Participants undergo a clinical examination to identify the presence of the Linburg-Comstock Variation (LCV)

10 seconds

1 visit (in-person)

Data Collection

Demographic and dichotomous data are collected to determine the presence of LCV in one or both hands

Up to 2 years

Follow-up

Participants are informed of their LCV status during the clinical examination

Immediate

Treatment Details

Interventions

• Descriptive

Trial Overview The study is descriptive and aims to investigate the prevalence of Linburg-Comstock Variation (LCV), a tendon connection in the wrist, among patients with CMC arthritis to see if there's an association between LCV and painful CMC arthritis.

Participant Groups

Group I: Positive LCV Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Russell Sage College

Lead Sponsor

Trials

3

Recruited

580+

Albany Medical College

Collaborator

Trials

96

Recruited

12,700+