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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date March 2021
Source Töölö Hospital
Contact Samuli Aspinen, M.D., Ph.D.
Phone +358406360546
Email samuli.aspinen@hus.fi
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

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

Study Design


Intervention

Procedure:
Trapeziectomy
Simple trapeziectomy (without LRTI)

Locations

Country Name City State
Finland Töölö Hospital (Helsinki University Hospital) Helsinki

Sponsors (1)

Lead Sponsor Collaborator
Töölö Hospital

Country where clinical trial is conducted

Finland, 

Outcome

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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