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

NCT06263569 | Completed

• 1 other identifier: SDB 2023-002
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Numerical Rating Scale (NRS) pain during weight bearing, change score from baseline

  3 months

Study Arms (2)

Total hip arthroplasty (THA)

Total hip arthroplasty surgery

Procedure: Total hip arthroplasty

Non-Total hip arthroplasty (THA)

No total hip arthroplasty surgery performed / control group.

Interventions

Total hip arthroplasty PROCEDURE

Unilateral primary total hip arthroplasty procedure.

Total hip arthroplasty (THA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• JointResearch: lead

Study Sites (1)

OLVG

Amsterdam, North Holland, 1090 HM, Netherlands

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Rudolf Poolman, Prof.

  OLVG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: February 16, 2024
• Study Start: May 24, 2023
• Primary Completion: May 24, 2023
• Study Completion: May 24, 2023
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)