Back to resultsThumb Basal Joint (CMC I) Arthritis - Preoperative Anxiety/Depression, Outcome Instruments, Carpal Cinematics and Cost-utility
Primary Purpose
Arthritis, Thumb Osteoarthritis, Arthropathy
Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Trapeziectomy
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis
Eligibility Criteria
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
Sites / Locations
- Töölö Hospital (Helsinki University Hospital)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Trapeziectomy
Conservative
Arm Description
Simple trapeziectomy for treating CMC I arthritis
Conservative measures (e.g. splint, NSAID, activation modification) for treating CMC I arthritis
Outcomes
Primary Outcome Measures
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)
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.
Secondary Outcome Measures
Pain Catastrophizing Scale
A pain catastrophizing scale comprising of three subscales: (1) Helplessness, (2) Rumination, and (3) Magnification
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)
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
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
Wrist and hand (thumb) range of motion (ROM)
ROM is measured on both hands with a handheld goniometer in degrees.
Cost-utility
Quality-adjusted life years/months measured as a change in EQ-5D
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)
Beck Depression Inventory
21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04826380
Brief Title
Thumb Basal Joint (CMC I) Arthritis - Preoperative Anxiety/Depression, Outcome Instruments, Carpal Cinematics and Cost-utility
Official Title
Thumb Basal Joint (CMC I) Arthritis - Preoperative Anxiety/Depression, Outcome Instruments, Carpal Kinematics and Cost-utility
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2021 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Töölö Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Thumb Osteoarthritis, Arthropathy, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Trapeziectomy
Arm Type
Other
Arm Description
Simple trapeziectomy for treating CMC I arthritis
Arm Title
Conservative
Arm Type
No Intervention
Arm Description
Conservative measures (e.g. splint, NSAID, activation modification) for treating CMC I arthritis
Intervention Type
Procedure
Intervention Name(s)
Trapeziectomy
Intervention Description
Simple trapeziectomy (without LRTI)
Primary Outcome Measure Information:
Title
Patient-Rated Wrist Evaluation
Description
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)
Time Frame
12 months
Title
Michigan Hand Outcome Questionnaire
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Pain Catastrophizing Scale
Description
A pain catastrophizing scale comprising of three subscales: (1) Helplessness, (2) Rumination, and (3) Magnification
Time Frame
12 months
Title
Pain (Visual Analogue Scale)
Description
The VAS is derived by health care professional question of pain in scale 0 to 10 (0=no pain, 10=worst possible pain)
Time Frame
12 months
Title
Global improvemen
Description
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
Time Frame
12 months
Title
Grip strength
Description
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
Time Frame
12 months
Title
Wrist and hand (thumb) range of motion (ROM)
Description
ROM is measured on both hands with a handheld goniometer in degrees.
Time Frame
12 months
Title
Cost-utility
Description
Quality-adjusted life years/months measured as a change in EQ-5D
Time Frame
12 months
Title
Carpal Kinematics
Description
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)
Time Frame
12 months
Title
Beck Depression Inventory
Description
21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samuli Aspinen, M.D., Ph.D.
Phone
+358406360546
Email
samuli.aspinen@hus.fi
Facility Information:
Facility Name
Töölö Hospital (Helsinki University Hospital)
City
Helsinki
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuli Aspinen, M.D., Ph.D.
Phone
+358406360546
Email
samuli.aspinen@hus.fi
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The datasets generated and analyzed during this trial will be available from the PI on reasonable request.
Learn more about this trial
Thumb Basal Joint (CMC I) Arthritis - Preoperative Anxiety/Depression, Outcome Instruments, Carpal Cinematics and Cost-utility
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