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

JointResearch

Status

Completed

Conditions

Hip Osteoarthritis

Treatments

Procedure: Total hip arthroplasty

Study type

Observational

Funder types

Other

Identifiers

NCT06263569

SDB 2023-002

Details and patient eligibility

About

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.

Full 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.

Enrollment

156 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.