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

Sponsor

Töölö Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04826380

Collaborator

(none)

150

Enrollment

Location

Arms

48.1

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Arthritis Thumb Osteoarthritis Arthropathy Quality of Life	Procedure: Trapeziectomy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 29, 2021

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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)
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.

Secondary Outcome Measures

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)
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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Töölö Hospital (Helsinki University Hospital)	Helsinki		Finland

Sponsors and Collaborators

Töölö Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Samuli Aspinen, Principal investigator, Töölö Hospital

ClinicalTrials.gov Identifier:

NCT04826380

Other Study ID Numbers:

3163/2020

First Posted:

Apr 1, 2021

Last Update Posted:

Apr 2, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Arthritis

Study Results

No Results Posted as of Apr 2, 2021