The Prevalence of the Linburg-Comstock Variation

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	35 Years - 89 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- • 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.

Exclusion Criteria:

- Under the age of 35.

- Over the age of 89.

- Prisoners

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06142370
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Russell Sage College
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Chris Mulligan
Principal Investigator Affiliation	Russell Sage College
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Anomaly; Hand

Additional Details

Five hundred male and female patients over the age of 35 will be recruited to participate through convenience sampling. This is a descriptive cross-sectional study of patients with a diagnosis of thumb CMC arthritis. There is no control group due to the recruitment of one patient population. Once enrolled, commitment of the participants will consist of one time during their regular office visit. 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. Subjects meeting the inclusion criteria will be consented during office clinic visit with Dr. Michael Mulligan, Dr. Richard Uhl, Dr. Patrick Marinello, Dr. Andrew Morse, Dr. George Zanaros, Dr. Whipple and Dr. David Quinn. The descriptive study will collect demographic data, and dichotomous data indicating whether a patient has the variation or does not have the variation, and if the variation is present in one hand or both hands. The study will take place at the Bone and Joint Center at 1365 Washington Avenue, Albany New York, and satellite offices in Guilderland, Clifton Park, Malta, Saratoga, Schenectady and Catskill. Data will be collected for up to two years. There are no risks to patients enrolled in the study, as the test involves asking the patient to simply bend the tip of their thumb. Documentation of the variation is not usually noted in the chart. Therefore, the physicians involved in the study will be asked to include the findings of the variation in their documentation. The patients will be informed during clinical examination if they have a LCV. There is no compensation to participants for enrolling in the study.

Arms & Interventions

Arms

Other: Positive LCV

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

Interventions

Other: - Descriptive

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

The Bone and Joint Center, Albany, New York

Status

Address

The Bone and Joint Center

Albany, New York, 12204

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