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ENROLLING BY INVITATION
NCT06367829

Lubinus SPII Hip Stem Target Trial Emulation (LARGE)

Sponsor: JointResearch

View on ClinicalTrials.gov

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.

Official title: Comparing Mortality, Revision Rates, and Patient-Reported Outcomes With Different Stem Lengths of the Lubinus SPII Cemented Hip Stem: A Target Trial Emulation.

Key Details

Gender

All

Age Range

5 Years - 105 Years

Study Type

OBSERVATIONAL

Enrollment

110000

Start Date

2024-01-08

Completion Date

2025-12-31

Last Updated

2025-11-18

Healthy Volunteers

No

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

Locations (1)

OLVG

Amsterdam, North Holland, Netherlands