Anomaly; HandLCVNCT06142370
The Prevalence of the Linburg-Comstock Variation
A study testing Descriptive in people with Anomaly; Hand, run by Russell Sage College at 1 site in United States.
Trial 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.… Read more about this study
- Who is it for?
- Ages 35 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Anomaly; Hand
- What is being tested?
- Descriptive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2022to 10 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- Under the age of 35
- Over the age of 89
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prevalence of the Linburg-Comstock Variation in Patients With Symptomatic Thumb CMC Arthritis
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.
Read the 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.
- Conditions
- Anomaly; Hand
- Being tested
- Descriptive
- Medical subject headings
- Hand Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DescriptiveOther
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
| Study group | Role | What they receive |
|---|---|---|
| Positive LCV | Other | A patient who tests positive by clinical exam of a LCV. Receives: Other: Descriptive |
What is being measured
The primary outcome is the main question the study is designed to answer.
LCV
A positive or negative clinical exam
Measured: 10 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start7 May 2022
- Primary completion10 May 2024 (estimated)
- Study completion10 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anomaly; HandStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russell Sage College
- Sponsor type
- University, hospital or other
- Collaborators
- Albany Medical College
- Responsible party
- Principal investigator, Christine Mulligan, Russell Sage College
- Investigators
- Chris Mulligan, Principal investigator, Russell Sage College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142370
- Sponsor's protocol ID
- RussellSage1
- Acronym
- LCV
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of the Linburg-Comstock Variation in Patients With Symptomatic Thumb CMC Arthritis
- ClinicalTrials.gov ID
- NCT06142370
- Acronym / sponsor ID
- LCV / RussellSage1
- Conditions
- Anomaly; Hand
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Russell Sage CollegeUniversity, hospital or other
- Collaborators
- Albany Medical College
- Study start
- 7 May 2022 (actual)
- Primary completion
- 10 May 2024 (estimated)
- Study completion
- 10 May 2025 (estimated)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Positive LCV | Other | Other: DescriptiveA patient who tests positive by clinical exam of a LCV. |
Who may qualify
- Ages
- 35 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Male and female
Key exclusion criteria (3 listed)
- Under the age of 35
- Over the age of 89
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DescriptiveThe 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 | Other | Positive LCV |
Primary outcome
LCV
Time frame: 10 seconds
A positive or negative clinical exam
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Mulligan principal investigator
Russell Sage College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Descriptive in people with Anomaly; Hand, run by Russell Sage College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LCV (time frame: 10 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.