Osteoarthrosis of the Carpometacarpal Joint of the Thumb Clinical Trial
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.
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.
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
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