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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04826380
• Other study ID #: 3163/2020
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Arthritis
• Arthropathy
• Joint Diseases
• Quality of Life
• Thumb Osteoarthritis

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