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

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

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

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Arthritis; Arthropathy; Thumb Osteoarthritis
• Intervention / Treatment: Procedure: Trapeziectomy

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • Recruiting
    • Töölö Hospital (Helsinki University Hospital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Trapeziectomy; Simple trapeziectomy for treating CMC I arthritis	Procedure: Trapeziectomy; Simple trapeziectomy (without LRTI)
No Intervention: Conservative; Conservative measures (e.g. splint, NSAID, activation modification) for treating CMC I arthritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Pain Catastrophizing Scale	A pain catastrophizing scale comprising of three subscales: (1) Helplessness, (2) Rumination, and (3) Magnification	12 months
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
Wrist and hand (thumb) range of motion (ROM)	ROM is measured on both hands with a handheld goniometer in degrees.	12 months
Cost-utility	Quality-adjusted life years/months measured as a change in EQ-5D	12 months
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
Beck Depression Inventory	21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression	12 months

Collaborators and Investigators

• Sponsor: Töölö Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2021
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): April 1, 2025

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 2, 2021
• Last Update Submitted That Met QC Criteria: March 31, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: 3163/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The datasets generated and analyzed during this trial will be available from the PI on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No