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

NCT04826380 | Unknown

• 1 other identifier: 3163/2020
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Arthritis; Thumb Osteoarthritis; Arthropathy; Quality of Life

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Pain Catastrophizing Scale

  12 months

• Pain (Visual Analogue Scale)

  12 months

• Global improvemen

  12 months

• Grip strength

  12 months

• Wrist and hand (thumb) range of motion (ROM)

  12 months

Study Arms (2)

Trapeziectomy

OTHER

Simple trapeziectomy for treating CMC I arthritis

Procedure: Trapeziectomy

Conservative

NO INTERVENTION

Conservative measures (e.g. splint, NSAID, activation modification) for treating CMC I arthritis

Interventions

Trapeziectomy PROCEDURE

Simple trapeziectomy (without LRTI)

Trapeziectomy

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eaton-Glickel \>2 arhritis
• Symptom duration \>3 months
• Pain VAS \>30mm
• No significant comorbidities, ASA I-II
• Fluent in Finnish language

You may not qualify if:

• 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

Sponsors & Collaborators

• Töölö Hospital: lead

Study Sites (1)

Töölö Hospital (Helsinki University Hospital)

Helsinki, Finland

RECRUITING

MeSH Terms

Conditions

Arthritis; Joint Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Central Study Contacts

Samuli Aspinen, M.D., Ph.D.

CONTACT

+358406360546; samuli.aspinen@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 1, 2021
• Study Start: March 29, 2021
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2025
• Last Updated: April 2, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share

Locations

FI (1)