Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06263569
Status:
COMPLETED
Last Update Posted:
2024-02-16
First Post:
2024-01-12
Brief Title:
Effectiveness of Total Hip Arthroplasty for Patients With Osteoarthritis a Target Trial Emulation Study
Sponsor:
JointResearch
Organization:
JointResearch
Study Overview
Official Title:
Effectiveness of Total Hip Arthroplasty for Patients With Osteoarthritis a Target Trial Emulation Study
Status:
COMPLETED
Status Verified Date:
2024-02
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:
EAGLE
Brief Summary:
The aim of this study is to assess the effect of total hip arthroplasty on hip disability and pain compared to non-surgery in patients with hip osteoarthritis using target trial emulation to emulate a randomized controlled trial
Detailed Description:
The ideal research design to investigate effectiveness of total hip arthroplasty THA would be to randomize patients between surgery and delayed non-surgery Such a randomized controlled trial RCT is deemed unethical due to the effect size of THA shown in observational studies
In this study a target trial is specified a randomized controlled trial between THA and non-THA and the target trial is emulated using observational data of 2 dutch hospitals participating in the value based health care VBHC programme for hip osteoarthritis The objective of this study is to compare the effect of THA surgery on hip disability and pain between patients that did or did not receive THA surgery during the Covid-19 pandemic It is hypothesized that THA is effective in restoring hip function and reduction of pain compared to the control group The effect of THA has not been demonstrated by means of an RCT before This study can contribute to the available evidence by assessing causal effectiveness of THA by means of RCT target trial emulation
As a secondary aim the assumption of pseudo-random group allocation will be assessed Logistic regression analysis will be used to test whether group allocation is independent of patient characteristics age sex HOOS-PS baseline NRS baseline physical therapy before baseline and follow-up time
In this study a target trial is specified a randomized controlled trial between THA and non-THA and the target trial is emulated using observational data of 2 dutch hospitals participating in the value based health care VBHC programme for hip osteoarthritis The objective of this study is to compare the effect of THA surgery on hip disability and pain between patients that did or did not receive THA surgery during the Covid-19 pandemic It is hypothesized that THA is effective in restoring hip function and reduction of pain compared to the control group The effect of THA has not been demonstrated by means of an RCT before This study can contribute to the available evidence by assessing causal effectiveness of THA by means of RCT target trial emulation
As a secondary aim the assumption of pseudo-random group allocation will be assessed Logistic regression analysis will be used to test whether group allocation is independent of patient characteristics age sex HOOS-PS baseline NRS baseline physical therapy before baseline and follow-up time
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None