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Migration in Total Hip Arthroplasty with a Cemented BiMobile Cup: Better Stability with More Cement?

NCT04049279 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-02-28

No results posted yet for this study

Summary

Objective: The main objective of this study is to compare the (early) migration of the cemented BiMobile cup at two year post-surgery between two different cup sizes after standard optimal reaming, and consequently adjusting the cement mantle into circa 2 or 4 mm, in patients with a primary cemented total hip arthroplasty (THA). Additionally, the results of the BiMobile cup will be compared to the Avantage cup, which is placed with a standard cup size, resulting in a cement mantle of approximately 2 mm.

Study design: A prospective single centre blinded randomised controlled trial.

Study population: All patients who meet the criteria to undergo a cemented THA.

Conditions

  • Total Hip Arthroplasty
  • Osteoarthritis, Hip

Interventions

PROCEDURE

BiMobile standard cement

BiMobile dual mobility cup, in a standard size after optimal reaming, resulting in a cement mantle of approximately 2mm.

PROCEDURE

BiMobile larger cement

BiMobile dual mobility cup, in one size smaller than standard after optimal reaming, resulting in a cement mantle of approximately 4mm.

PROCEDURE

Avantage standard cement

Avantage dual mobility cup, in a standard size after optimal reaming, resulting in a cement mantle of approximately 2mm.

Sponsors & Collaborators

  • JointResearch

    lead OTHER

Principal Investigators

  • Rudolf Poolman, MD, PhD · OLVG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2026-05-01
Completion
2029-05-01

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 NCT04049279 on ClinicalTrials.gov