Thumb Basal Joint (CMC I) Arthritis - Preoperative Anxiety/Depression, Outcome Instruments, Carpal Cinematics and Cost-utility

Study Overview
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Brief Summary
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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

Official Title
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Thumb Basal Joint (CMC I) Arthritis - Preoperative Anxiety/Depression, Outcome Instruments, Carpal Kinematics and Cost-utility

Conditions
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Arthritis, Thumb Osteoarthritis, Arthropathy, Quality of Life

Intervention / Treatment
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* Procedure: Trapeziectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Trapeziectomy<br>Simple trapeziectomy for treating CMC I arthritis | Procedure: Trapeziectomy<br>* Simple trapeziectomy (without LRTI)<br>|
| No Intervention: Conservative<br>Conservative measures (e.g. splint, NSAID, activation modification) for treating CMC I arthritis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Rated Wrist Evaluation | 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) | 12 months | 
| Michigan Hand Outcome Questionnaire | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Catastrophizing Scale | A pain catastrophizing scale comprising of three subscales: (1) Helplessness, (2) Rumination, and (3) Magnification | 12 months | 
| Pain (Visual Analogue Scale) | The VAS is derived by health care professional question of pain in scale 0 to 10 (0=no pain, 10=worst possible pain) | 12 months | 
| Global improvemen | 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 | 12 months | 
| Grip strength | 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 | 12 months | 
| Wrist and hand (thumb) range of motion (ROM) | ROM is measured on both hands with a handheld goniometer in degrees. | 12 months | 
| Cost-utility | Quality-adjusted life years/months measured as a change in EQ-5D | 12 months | 
| Carpal Kinematics | 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) | 12 months | 
| Beck Depression Inventory | 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression | 12 months |