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Dual-mobility Cups Compared to Unipolar Cups on Dislocation and Cost-effectiveness After Primary Total Hip Arthroplasty.

NCT04031820 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1100

Last updated 2025-02-28

No results posted yet for this study

Summary

Objective: The primary objective is to investigate whether there is a difference in the number of hip dislocations following primary total hip arthroplasty (THA), using the posterolateral approach, with a DM cup compared to a unipolar cup in elderly patients 1 year after surgery.

Study design: Prospective multi-center nation wide, single blinded RCT nested in the LROI.

Study population: Patients ≥ 70 years old, undergoing an elective primary cemented THA.

Conditions

  • Total Hip Arthroplasty
  • Osteoarthritis, Hip

Interventions

PROCEDURE

Unipolar cup

Cemented unipolar acetabulum cup for primary THA

PROCEDURE

Dual mobility cup

Cemented dual mobility acetabulum cup for primary THA

Sponsors & Collaborators

  • JointResearch

    lead OTHER

Principal Investigators

  • Rudolf Poolman, MD, PhD · OLVG, Amsterdam, the Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2026-05-01
Completion
2027-05-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04031820 on ClinicalTrials.gov