Osteoarthrosis of the Carpometacarpal Joint of the ThumbRASSHNCT01724853
Outcomes of Treatment for Trapeziometacarpal Osteoarthritis
A study testing Surgery and Conservative in people with Osteoarthrosis of the Carpometacarpal Joint of the Thumb, run by Schulthess Klinik at 1 site in Switzerland.
Trial summary
The main objective of the study is the evaluation of the outcomes following treatment for TMC OA using a set of variables covering all OMERACT categories as well as the dimensions of the International Classification of Functioning, Disability and Health (ICF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthrosis of the Carpometacarpal Joint of the Thumb
- What is being tested?
- Surgery and Conservative
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2011to Nov 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients diagnosed for TMC OA
- signed informed consent
Who cannot join
- rheumatoid arthritis,
- legal incompetent patients,
- patients already included in the study for the other hand,
- insufficient knowledge of the German language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Treatment for Trapeziometacarpal Osteoarthritis Using a Comprehensive Core Set.
The main objective of the study is the evaluation of the outcomes following treatment for TMC OA using a set of variables covering all OMERACT categories as well as the dimensions of the International Classification of Functioning, Disability and Health (ICF). Secondary aims are the analysis of the determinants of patient satisfaction with the treatment result, the evaluation of the psychometric properties of the Michigan Hand Outcomes Questionnaire (MHQ), which has not yet been established in TMC OA patients, as well as the economic impact associated with TMC OA.
Read the detailed description
Hand osteoarthritis is a frequent condition in the middle-aged and elderly population with a prevalence of up to 76%. After the distal interphalangeal joints, the trapeziometacarpal joints are the most affected joints of the hand. Symptoms such as pain, stiffness, deformity, loss of grip strength, as well as reduction of joint mobility, are affecting the overall hand function and patients' quality of life. Numerous studies have evaluated different surgical and conservative interventions for treating patients with trapeziometacarpal osteoarthritis (TMC OA) with both interventions found to be effective in reducing pain and increasing function. To date, there is only little evidence about the characteristics and outcomes of patients who receive a conservative or a surgical treatment for TMC OA. The analysis should focus on which factors contribute to either a conservative or a surgical treatment, and if these patients differ regarding personal or health-related factors. Furthermore, no data about the economic consequences of a resection interposition suspension arthroplasty are available which highlights the need for a financial analysis of this procedure with respect to the benefit for the patient and cost bearers.
Besides objective parameters, such as strength and range of motion, the evaluation of patient satisfaction as well as the fulfilment of preoperative expectation is becoming increasingly important as outcome measures. However, there is no standardized instrument available for measuring satisfaction, expectations and their fulfillment for TMC OA patients.
For measuring outcomes of OA, a core set for outcome measures for OA trials (hip, knee, hand) was developed at the OMERACT III conference. It comprised of the assessment of pain, physical function, patients' global condition and joint imaging. Furthermore, the evaluation of quality of life is recommended, but the specific items of this core set for TMC OA patients still remain to be defined.
The main objective of the study is the evaluation of the outcomes following treatment for TMC OA using a set of variables covering all OMERACT categories as well as the dimensions of the International Classification of Functioning, Disability and Health (ICF). Secondary aims are the analysis of the determinants of patient satisfaction with the treatment result, the evaluation of the psychometric properties of the Michigan Hand Outcomes Questionnaire (MHQ), which has not yet been established in TMC OA patients, as well as the economic impact associated with TMC OA.
In order to achieve these objectives, a prospective cohort study including patients with TMC OA will be conducted, regardless of if they will have surgery or not. A total of 100 surgically treated patients will be analysed during a one-year inclusion period and all conservatively treated patients will also be analysed during the same time. Follow up examinations will take place at 3, 6 and 12 months for all patients using a standardized set of objective as well as subjective outcome measurements including the MHQ.
- Being tested
- Surgery, Conservative
- Keywords
- Carpometacarpal, osteoarthritis, outcome measures
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Resection suspension interposition arthroplasty or Arthrodesis
ConservativeOther
Injection
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Other | Preferred surgery Receives: Procedure: Surgery |
| Conservative | Other | Conservative treatment Receives: Other: Conservative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Michigan Hand Questionnaire - pain subscale
Measured: 12 months
Secondary outcomes (1)
Disabilities of the Arm, Shoulder and Hand Questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2012 (estimated)
- Study startSep 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthrosis of the Carpometacarpal Joint of the ThumbStudies 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center
- Responsible party
- Principal investigator, Daniel Herren, Schulthess Klinik
- Investigators
- Daniel Herren, Dr., Principal investigator, Department of HandsurgeryMiriam Marks, MSc., Study chair, Department of Research and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724853
- Sponsor's protocol ID
- RASSH01
- Acronym
- RASSH
- Status last verified
- Nov 2013
- First submitted
- 1 Nov 2012
- Last updated
- 2 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Marks M, Audige L, Herren DB, Schindele S, Nelissen RG, Vliet Vlieland TP. Measurement properties of the German Michigan Hand Outcomes Questionnaire in patients with trapeziometacarpal osteoarthritis. Arthritis Care Res (Hoboken). 2014 Feb;66(2):245-52. doi: 10.1002/acr.22124.
PubMed 23982906
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Treatment for Trapeziometacarpal Osteoarthritis Using a Comprehensive Core Set.
- ClinicalTrials.gov ID
- NCT01724853
- Acronym / sponsor ID
- RASSH / RASSH01
- Keywords
- Carpometacarpal, osteoarthritis, outcome measures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Collaborators
- Leiden University Medical Center
- Study start
- Sep 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 12 Nov 2012 (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.
The main objective of the study is the evaluation of the outcomes following treatment for TMC OA using a set of variables covering all OMERACT categories as well as the dimensions of the International Classification of Functioning, Disability and Health (ICF). Secondary aims are the analysis of the determinants of patient satisfaction with the treatment result, the evaluation of the psychometric properties of the Michigan Hand Outcomes Questionnaire (MHQ), which has not yet been established in TMC OA patients, as well as the economic impact associated with TMC OA.
Detailed description
Hand osteoarthritis is a frequent condition in the middle-aged and elderly population with a prevalence of up to 76%. After the distal interphalangeal joints, the trapeziometacarpal joints are the most affected joints of the hand. Symptoms such as pain, stiffness, deformity, loss of grip strength, as well as reduction of joint mobility, are affecting the overall hand function and patients' quality of life. Numerous studies have evaluated different surgical and conservative interventions for treating patients with trapeziometacarpal osteoarthritis (TMC OA) with both interventions found to be effective in reducing pain and increasing function. To date, there is only little evidence about the characteristics and outcomes of patients who receive a conservative or a surgical treatment for TMC OA. The analysis should focus on which factors contribute to either a conservative or a surgical treatment, and if these patients differ regarding personal or health-related factors. Furthermore, no data about the economic consequences of a resection interposition suspension arthroplasty are available which highlights the need for a financial analysis of this procedure with respect to the benefit for the patient and cost bearers.
Besides objective parameters, such as strength and range of motion, the evaluation of patient satisfaction as well as the fulfilment of preoperative expectation is becoming increasingly important as outcome measures. However, there is no standardized instrument available for measuring satisfaction, expectations and their fulfillment for TMC OA patients.
For measuring outcomes of OA, a core set for outcome measures for OA trials (hip, knee, hand) was developed at the OMERACT III conference. It comprised of the assessment of pain, physical function, patients' global condition and joint imaging. Furthermore, the evaluation of quality of life is recommended, but the specific items of this core set for TMC OA patients still remain to be defined.
The main objective of the study is the evaluation of the outcomes following treatment for TMC OA using a set of variables covering all OMERACT categories as well as the dimensions of the International Classification of Functioning, Disability and Health (ICF). Secondary aims are the analysis of the determinants of patient satisfaction with the treatment result, the evaluation of the psychometric properties of the Michigan Hand Outcomes Questionnaire (MHQ), which has not yet been established in TMC OA patients, as well as the economic impact associated with TMC OA.
In order to achieve these objectives, a prospective cohort study including patients with TMC OA will be conducted, regardless of if they will have surgery or not. A total of 100 surgically treated patients will be analysed during a one-year inclusion period and all conservatively treated patients will also be analysed during the same time. Follow up examinations will take place at 3, 6 and 12 months for all patients using a standardized set of objective as well as subjective outcome measurements including the MHQ.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | Other | Procedure: SurgeryPreferred surgery |
| Conservative | Other | Other: ConservativeConservative treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All adult patients diagnosed for TMC OA
- signed informed consent
Key exclusion criteria (4 listed)
- rheumatoid arthritis,
- legal incompetent patients,
- patients already included in the study for the other hand,
- insufficient knowledge of the German language
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 |
|---|---|---|
| SurgeryResection suspension interposition arthroplasty or Arthrodesis | Procedure or surgery | Surgery |
| ConservativeInjection | Other | Conservative |
Primary outcome
Michigan Hand Questionnaire - pain subscale
Time frame: 12 months
1 secondary outcome
Disabilities of the Arm, Shoulder and Hand Questionnaire
Time frame: 12 months
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 2 Dec 2013.
- Derived from this study: PubMed 23982906Marks M, Audige L, Herren DB, Schindele S, Nelissen RG, Vliet Vlieland TP. Measurement properties of the German Michigan Hand Outcomes Questionnaire in patients with trapeziometacarpal osteoarthritis. Arthritis Care Res (Hoboken). 2014 Feb;66(2):245-52. doi: 10.1002/acr.22124.
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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.
Daniel Herren, Dr. principal investigator
Department of Handsurgery
Miriam Marks, MSc. study chair
Department of Research and Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery and Conservative in people with Osteoarthrosis of the Carpometacarpal Joint of the Thumb, run by Schulthess Klinik at 1 site in Switzerland.
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 2 inclusion and 4 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 2 Dec 2013. 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 Switzerland. 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?
Michigan Hand Questionnaire - pain subscale (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01724853, which also lists 1 linked publication.
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 2 Dec 2013; AzTrials last refreshed its copy on 8 Nov 2026.