Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05772715
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2022-12-23
Brief Title:
The THumb Osteoarthritis Exercise TriAl
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THETA
Brief Summary:
Summary
OBJECTIVESRESEARCH QUESTIONS 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 POPULATIONSDATASETS Patients with irst carpometacarpal osteoarthritis CMC-1 OA seeking treatment INTERVENTION Orthosis exercise therapy USUAL CARECOMPARISON Orthosis only OUTCOME MEASURES Primary outcomes pain and conversion to surgery SAMPLE SIZE CALCULATIONDATA ANALYSIS Two groups of 80 participants analysis based on repeated measures analysis for pain and Chi-square tests for conversion to surgery We initially planned to perform a survival analysis log-rank and 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 of conversion to surgery We made this decision due to low inclusion rates as chi-square tests require smaller sample sizes We will use a mixed-effect model 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 ie 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
OBJECTIVESRESEARCH QUESTIONS 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 POPULATIONSDATASETS Patients with irst carpometacarpal osteoarthritis CMC-1 OA seeking treatment INTERVENTION Orthosis exercise therapy USUAL CARECOMPARISON Orthosis only OUTCOME MEASURES Primary outcomes pain and conversion to surgery SAMPLE SIZE CALCULATIONDATA ANALYSIS Two groups of 80 participants analysis based on repeated measures analysis for pain and Chi-square tests for conversion to surgery We initially planned to perform a survival analysis log-rank and 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 of conversion to surgery We made this decision due to low inclusion rates as chi-square tests require smaller sample sizes We will use a mixed-effect model 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 ie 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None