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Completed

NCT Number: NCT06263569

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

OLVG

Amsterdam, North Holland, 1090 HM, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Total Hip Arthroplasty

Procedure

Unilateral primary total hip arthroplasty procedure.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

JointResearch

Other

Registry information

Acronym: EAGLE

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 16, 2024
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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