Arthritis, Arthropathy, Quality of Life, Thumb Osteoarthritis
Conditions
Brief summary
A project aiming to promote evidence based practice when treating thumb basal joint (CMC I) arthritis. We will aim to: 1) provide the minimal clinical difference of two general outcome instruments, 2) evaluate the association between pre-operative anxiety and/or depression and outcomes following trapeziectomy, 3) evaluate the effect of trapziectomy on carpal cinematics, 4) determine the cost-utility-ratio of trapeziectomy
Interventions
PROCEDURETrapeziectomy
Simple trapeziectomy (without LRTI)
Sponsors
Töölö Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Eaton-Glickel \>2 arhritis * Symptom duration \>3 months * Pain VAS \>30mm * No significant comorbidities, ASA I-II * Fluent in Finnish language
Exclusion criteria
* Eaton-Glickel \<2 * Duration of symptoms \<3 months * VAS \<30mm * ASA \>II * Inflammatory joint disease * Systemic corticosteroid or immunomodulatory medication * Upper limb symptoms not explained with CMC I artritis * Heavy smoking (\> 20 cigarettes per day) * Alcohol or drug abuse * Neurological condition affecting upper limb function * Other ipsilateral upper limb condition requiring surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Rated Wrist Evaluation | 12 months | The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists two subscales: Pain and Function (0=best possible outcome, 10=worst possible outcome) |
| Michigan Hand Outcome Questionnaire | 12 months | A hand-specific outcomes instrument that contains six distinct scales: (1) overall hand function, (2) activities of daily living, (3) pain, (4) work performance, (5) aesthetics, and (6) patient satisfaction with hand function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global improvemen | 12 months | Global rating to treatment effect will be evaluated by question: How would you rate the function of your hand compared to the situation before the treatment?. The options are in 5-step Likert scale from (-2) Much worse to (+2) Much better |
| Grip strength | 12 months | Grip strength is measured with a dynamometer in kg as the mean of three measurements. It will be numbered in kg and percentage of the unaffected side |
| Wrist and hand (thumb) range of motion (ROM) | 12 months | ROM is measured on both hands with a handheld goniometer in degrees. |
| Pain Catastrophizing Scale | 12 months | A pain catastrophizing scale comprising of three subscales: (1) Helplessness, (2) Rumination, and (3) Magnification |
| Carpal Kinematics | 12 months | Evaluated from preoperative and compared to 1-year postoperative 4-dimension cone-beam tomography - the wrists are imaged in 7 different postures to reproduce carpal movement, the pre and postoperative scans will be compared to evalueate the effect of trapeziectomy on carpal kinematics (e.g. scapholunate angle, lunotriquetral angle, metacarpal subsidence) |
| Beck Depression Inventory | 12 months | 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression |
| Cost-utility | 12 months | Quality-adjusted life years/months measured as a change in EQ-5D |
| Pain (Visual Analogue Scale) | 12 months | The VAS is derived by health care professional question of pain in scale 0 to 10 (0=no pain, 10=worst possible pain) |
Countries
Finland
Contacts
Primary ContactSamuli Aspinen, M.D., Ph.D.
Outcome results
None listed