Thumb ArthritisNCT01133197
The Impact of Thumb Carpometacarpal Osteoarthritis on General Health
An observational study of Thumb Arthritis, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study is designed to define the impact of thumb arthritis on patient's general health. As a secondary objective, data will be analyzed to determine the effects of medical and musculoskeletal comorbidities on the rating of upper extremity function by the patient. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thumb Arthritis
- How many people
- 188 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jun 2015
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients presenting for treatment have thumb arthritis
Who may be able to join
- Healthy adults clinically diagnosed with thumb carpometacarpal osteoarthritis. The diagnosis must have been confirmed radiographically prior to consideration for study enrollment.
- Adults accompanying patients to participating offices will be recruited to be control subjects. They must not be receiving medical or surgical treatment for a hand or wrist complaint.
- Additionally control subjects must not have been diagnosed with thumb osteoarthritis.
Who cannot join
- Subjects must be over 18 years of age and English speaking.
- Subjects are not to include incarcerated adults or those unable to provide consent for study participation.
- Patients diagnosed with currently symptomatic hand or wrist pathology outside of the thumb carpometacarpal joint will be excluded.
- Patient with prior surgery on the affected thumb will be excluded.
- Pregnant females are excluded from study participation with pregnancy determined by patient self-reporting (standard of care before office radiographs).
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to define the impact of thumb arthritis on patient's general health. As a secondary objective, data will be analyzed to determine the effects of medical and musculoskeletal comorbidities on the rating of upper extremity function by the patient.
Read the detailed description
This study is designed to define the impact of thumb arthritis on patient's general health. As a secondary objective, data will be analyzed to determine the effects of medical and musculoskeletal comorbidities on the rating of upper extremity function by the patient.
Potential Contribution: The data that we intend to gather could further our understanding of the overall health impact of thumb osteoarthritis and allow surgeons to more accurately interpret patient-rated measures of upper extremity function in the presence of comorbidities.
Osteoarthritis of the thumb carpometacarpal joint is one of the most common sites of arthritic degeneration in the hand. To date, no study has examined this conditions impact on overall health using a validated health measure (e.g. SF-36). Additionally, no study has examined the impact of medical and musculoskeletal comorbidities on patient-rated measures of upper extremity function in these patients.
- Conditions
- Thumb Arthritis
- Keywords
- thumb, arthritis, Impact of thumb arthritis on health
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| controls | No hand arthritis | |
| CMC Arthritis | Patients with arthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand Function
Use of hand by Michigan Hand Questionnaire
Measured: Baseline
Secondary outcomes (1)
Overall Health
SF-36
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startJul 2009
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thumb ArthritisStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rochester
- Responsible party
- Principal investigator, Ryan Calfee, MD, Washington University School of Medicine
- Investigators
- Ryan P Calfee, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133197
- Sponsor's protocol ID
- 09-0829
- Status last verified
- Jun 2015
- First submitted
- 26 May 2010
- Last updated
- 29 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Thumb Carpometacarpal Osteoarthritis on General Health
- ClinicalTrials.gov ID
- NCT01133197
- Acronym / sponsor ID
- 09-0829
- Conditions
- Thumb Arthritis
- Keywords
- thumb, arthritis, Impact of thumb arthritis on health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- University of Rochester
- Study start
- Jul 2009
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 28 May 2010 (estimated)
- 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.
This study is designed to define the impact of thumb arthritis on patient's general health. As a secondary objective, data will be analyzed to determine the effects of medical and musculoskeletal comorbidities on the rating of upper extremity function by the patient.
Detailed description
This study is designed to define the impact of thumb arthritis on patient's general health. As a secondary objective, data will be analyzed to determine the effects of medical and musculoskeletal comorbidities on the rating of upper extremity function by the patient.
Potential Contribution: The data that we intend to gather could further our understanding of the overall health impact of thumb osteoarthritis and allow surgeons to more accurately interpret patient-rated measures of upper extremity function in the presence of comorbidities.
Osteoarthritis of the thumb carpometacarpal joint is one of the most common sites of arthritic degeneration in the hand. To date, no study has examined this conditions impact on overall health using a validated health measure (e.g. SF-36). Additionally, no study has examined the impact of medical and musculoskeletal comorbidities on patient-rated measures of upper extremity function in these patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| controls | – | –No hand arthritis |
| CMC Arthritis | – | –Patients with arthritis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients presenting for treatment have thumb arthritis
Key inclusion criteria (3 listed)
- Healthy adults clinically diagnosed with thumb carpometacarpal osteoarthritis. The diagnosis must have been confirmed radiographically prior to consideration for study enrollment.
- Adults accompanying patients to participating offices will be recruited to be control subjects. They must not be receiving medical or surgical treatment for a hand or wrist complaint.
- Additionally control subjects must not have been diagnosed with thumb osteoarthritis.
Key exclusion criteria (5 listed)
- Subjects must be over 18 years of age and English speaking.
- Subjects are not to include incarcerated adults or those unable to provide consent for study participation.
- Patients diagnosed with currently symptomatic hand or wrist pathology outside of the thumb carpometacarpal joint will be excluded.
- Patient with prior surgery on the affected thumb will be excluded.
- Pregnant females are excluded from study participation with pregnancy determined by patient self-reporting (standard of care before office radiographs).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hand Function
Time frame: Baseline
Use of hand by Michigan Hand Questionnaire
1 secondary outcome
Overall Health
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2015.
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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.
Ryan P Calfee, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thumb Arthritis, run by Washington University School of Medicine 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 29 Jun 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hand Function (time frame: Baseline). 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 29 Jun 2015.