Effectiveness of Total Hip Arthroplasty for Patients With Osteoarthritis, a Target Trial Emulation Study (EAGLE)

February 8, 2024 updated by: Rudolf Poolman, JointResearch
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord Holland
      • Amsterdam, Noord Holland, Netherlands, 1090 HM
        • OLVG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with hip osteoarthritis, eligible for primary total hip arthroplasty.

Description

Inclusion Criteria:

  • Patients on the waiting list for primary THA between 1-4-2020 up until 31-3-2022 in OLVG or Martini hospital.
  • Completed intake questionnaire (HOOS-PS baseline)
  • Indication osteoarthritis of the hip

Exclusion Criteria:

  • Patients that received THA on both sides within follow-up (1-4-2020 and 1-1-2022) will be excluded.
  • Patients with other indications than osteoarthritis of the hip were excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Total hip arthroplasty (THA)
Total hip arthroplasty surgery
Procedure: Total hip arthroplasty
Unilateral primary total hip arthroplasty procedure.
Non-Total hip arthroplasty (THA)
No total hip arthroplasty surgery performed / control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hip disability and Osteoarthritis Outcome Score Physical function Short form (HOOS-PS), change score from baseline
Time Frame: 3 months
Ranging from 0 (no difficulty) to 100 (extreme difficulty)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical Rating Scale (NRS) pain during weight bearing, change score from baseline
Time Frame: 3 months
Ranging from 0 (no pain) to 10 (worst pain)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JointResearch

Investigators

  • Principal Investigator: Rudolf Poolman, Prof., OLVG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2023

Primary Completion (Actual)

May 24, 2023

Study Completion (Actual)

May 24, 2023

Study Registration Dates

First Submitted

January 12, 2024

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDB 2023-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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