Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06142370
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-11-21
First Post:
2023-11-16
Brief Title:
The Prevalence of the Linburg-Comstock Variation
Sponsor:
Russell Sage College
Organization:
Russell Sage College
Study Overview
Official Title:
The Prevalence of the Linburg-Comstock Variation in Patients With Symptomatic Thumb CMC Arthritis
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LCV
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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None