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Lubinus SPII Hip Stem Target Trial Emulation

NCT06367829 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 110000

Last updated 2026-05-14

No results posted yet for this study

Summary

The research questions this study aims to answer are as follows:

Primary research question:

"Do primary total hip arthroplasties for patients with OA, hip fracture or osteonecrosis with the 150mm Lubinus SPII hip stem have better mortality and stem revision rates than primary total hip arthroplasties with the 130mm hip stem?"

Secondary aims include:

* How does line-to-line cementation, compare to undersized cementation in primary total hip arthroplasty for patients with OA, hip fracture, or osteonecrosis when comparing equal size Lubinus SPII hip stems implanted with different cementation techniques?
* Does the Lubinus SPII 150mm hip stem perform equal to the Lubinus SPII 130mm hip stem in primary total hip arthroplasties for patients with OA, hip fracture or osteonecrosis when comparing patient reported outcome measures?

To answer these questions, this study has been allowed use of registered data from the LROI (dutch arthroplasty registry) and the SAR (swedish arthroplasty registry). After exclusion of patients who did not meet inclusion criteria between 2007-2020, approximately 110000 patients remain eligible for analysis.

Conditions

  • Treatment Outcome

Interventions

PROCEDURE

Lubinus SPII hip stem 130mm

Shorter length of the SPII hip stem

PROCEDURE

Lubinus SPII hip stem 150mm

Longer length of the SPII hip stem

Sponsors & Collaborators

  • OLVG

    collaborator NETWORK

  • Uppsala University

    collaborator OTHER

  • Göteborg University

    collaborator OTHER

  • Leiden University Medical Center

    collaborator OTHER

  • JointResearch

    lead OTHER

Principal Investigators

  • Rudolf Poolman, Prof. Dr. · OLVG

  • Ariena Rasker, MSc · Joint research OLVG

  • Tijs de Koningh · Joint research OLVG

Eligibility

Min Age
5 Years
Max Age
105 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-08
Primary Completion
2026-12-31
Completion
2026-12-31

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 NCT06367829 on ClinicalTrials.gov