Thumb Basal Joint (CMC I) Arthritis - Preoperative Anxiety/Depression, Outcome Instruments, Carpal Cinematics and Cost-utility
- Conditions
- Thumb OsteoarthritisQuality of LifeArthritisArthropathy
- Interventions
- Procedure: Trapeziectomy
- Registration Number
- NCT04826380
- Lead Sponsor
- Töölö Hospital
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- Eaton-Glickel >2 arhritis
- Symptom duration >3 months
- Pain VAS >30mm
- No significant comorbidities, ASA I-II
- Fluent in Finnish language
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Trapeziectomy Trapeziectomy Simple trapeziectomy for treating CMC I arthritis
- Primary Outcome Measures
Name Time Method 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.
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)
- Secondary Outcome Measures
Name Time Method Pain Catastrophizing Scale 12 months A pain catastrophizing scale comprising of three subscales: (1) Helplessness, (2) Rumination, and (3) Magnification
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)
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.
Cost-utility 12 months Quality-adjusted life years/months measured as a change in EQ-5D
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
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
Trial Locations
- Locations (1)
Töölö Hospital (Helsinki University Hospital)
🇫🇮Helsinki, Finland