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

Hip Osteoarthritis Clinical Trial

— EAGLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06263569
• Other study ID #: SDB 2023-002
• Status: Completed
• Start date: May 24, 2023
• Est. completion date: May 24, 2023

Study information

• Verified date: February 2024
• Source: JointResearch
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: May 24, 2023
• Est. primary completion date: May 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Procedure:
• Total hip arthroplasty
Unilateral primary total hip arthroplasty procedure.

Locations

Country	Name	City	State
Netherlands	OLVG	Amsterdam	Noord Holland

Sponsors (1)

Lead Sponsor	Collaborator
JointResearch

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hip disability and Osteoarthritis Outcome Score Physical function Short form (HOOS-PS), change score from baseline	Ranging from 0 (no difficulty) to 100 (extreme difficulty)	3 months
Secondary	Numerical Rating Scale (NRS) pain during weight bearing, change score from baseline	Ranging from 0 (no pain) to 10 (worst pain)	3 months