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The THumb Osteoarthritis Exercise TriAl — THETA  

Thumb Osteoarthritis Clinical Trial

Official title:
The THumb Osteoarthritis Exercise TriAl (THETA); a Multicenter, Randomized Controlled Trial on Exercise Therapy With an Orthosis Compared to an Orthosis Alone in Patients With Thumb Base Osteoarthritis

Clinical Trial Summary

Summary: OBJECTIVE(S)/RESEARCH QUESTION(S) Does an orthosis combined with exercise therapy results in less pain and less conversion to surgery than an orthosis alone in patients with first carpometacarpal osteoarthritis (CMC-1 OA), at three months and one year after the start of treatment? HYPOTHESIS We hypothesize that the orthosis + exercise therapy group has less pain and conversion to surgery will be lower than the orthosis group. STUDY DESIGN Randomized controlled multicenter trial STUDY POPULATION(S)/DATASETS Patients with irst carpometacarpal osteoarthritis (CMC-1 OA) seeking treatment INTERVENTION Orthosis + exercise therapy USUAL CARE/COMPARISON Orthosis only OUTCOME MEASURES Primary outcomes: pain and conversion to surgery SAMPLE SIZE CALCULATION/DATA ANALYSIS Two groups of 80 participants; analysis based on repeated measures analysis (for pain) and chi-squared (for conversion to surgery). We initially planned to perform a logistic regression for conversion to surgery but decided prior to data analysis that we will be using Chi-square tests to determine whether there is a between-group difference in the proportion converting to surgery. We will use a repeated measures analysis for pain. COST-EFFECTIVENESS ANALYSIS (CEA)/ BUDGET IMPACT ANALYSIS (BIA) Economic evaluation will be done from societal & healthcare perspectives, according cost-effectiveness analysis (CEA) guidelines. Medical & non-medical costs and consequences (i.e. productivity loss) will be collected and taken into account. Both CEA and cost-utility analysis will be performed, using conversion to surgery and Quality-adjusted life years (QALYs), respectively TIME SCHEDULE Start preparation: December 2019, inclusion: October 2020- December 2022, final report: December 2023

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05772715
Study type Interventional
Source Erasmus Medical Center
Contact
Status Completed
Phase N/A
Start date September 1, 2020
Completion date February 15, 2024
View Details
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