Clinical trial NCT06263569: Effectiveness of Total Hip Arthroplasty for Patients With Osteoarthritis, a Target Trial Emulation Study
Official title: Effectiveness of Total Hip Arthroplasty for Patients With Osteoarthritis, a Target Trial Emulation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Osteoarthritis
Lead sponsor: JointResearch
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hip osteoarthritis, eligible for primary total hip arthroplasty.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hip disability and Osteoarthritis Outcome Score Physical function Short form (HOOS-PS), change score from baseline
timeFrame: 3 months
Secondary outcomes:
measure: Numerical Rating Scale (NRS) pain during weight bearing, change score from baseline
timeFrame: 3 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: OLVG
state: Noord Holland
Study officials:
affiliation: OLVG
name: Rudolf Poolman, Prof.
role: PRINCIPAL_INVESTIGATOR
References: