Effectiveness of Total Hip Arthroplasty for Patients With Osteoarthritis, a Target Trial Emulation Study
NCT ID: NCT06263569
Last Updated: 2024-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
156 participants
OBSERVATIONAL
2023-05-24
2023-05-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Randomized Controlled Trial of Total Hip Arthroplasty
NCT05093361
Clinical Phenotypes in Persons With Hip Osteoarthritis and Prognostic Factors for Outcome After Total Hip Arthroplasty
NCT05265858
A Randomised Trial Comparing Anterior Versus Posterior Approach in Total Hip Replacement
NCT01106560
A Trial Comparing Mini-posterior Approach and Direct Anterior Approach
NCT01024309
Effectiveness of Contemporary Knee Arthroplasty in Working-age Patients
NCT03233620
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Total hip arthroplasty (THA)
Total hip arthroplasty surgery
Total hip arthroplasty
Unilateral primary total hip arthroplasty procedure.
Non-Total hip arthroplasty (THA)
No total hip arthroplasty surgery performed / control group.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Total hip arthroplasty
Unilateral primary total hip arthroplasty procedure.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Completed intake questionnaire (HOOS-PS baseline)
* Indication osteoarthritis of the hip
Exclusion Criteria
* Patients with other indications than osteoarthritis of the hip were excluded.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
JointResearch
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rudolf Poolman
Prof. dr.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rudolf Poolman, Prof.
Role: PRINCIPAL_INVESTIGATOR
OLVG
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
OLVG
Amsterdam, North Holland, Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SDB 2023-002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.