Quality of Life Clinical Trial
Official title:
Thumb Basal Joint (CMC I) Arthritis - Preoperative Anxiety/Depression, Outcome Instruments, Carpal Kinematics and Cost-utility
NCT number | NCT04826380 |
Other study ID # | 3163/2020 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 29, 2021 |
Est. completion date | April 1, 2025 |
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
Status | Recruiting |
Enrollment | 150 |
Est. completion date | April 1, 2025 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Finland | Töölö Hospital (Helsinki University Hospital) | Helsinki |
Lead Sponsor | Collaborator |
---|---|
Töölö Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Pain Catastrophizing Scale | A pain catastrophizing scale comprising of three subscales: (1) Helplessness, (2) Rumination, and (3) Magnification | 12 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Wrist and hand (thumb) range of motion (ROM) | ROM is measured on both hands with a handheld goniometer in degrees. | 12 months | |
Secondary | Cost-utility | Quality-adjusted life years/months measured as a change in EQ-5D | 12 months | |
Secondary | 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 | |
Secondary | Beck Depression Inventory | 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression | 12 months |
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