Clinical Trial

Lubinus SPII Hip Stem Target Trial Emulation

Study acronym: LARGE
Enrolling by Invitation
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-04-10; most recent amendment 2026-05-11.
Trial Details
NCT Number NCT06367829
Lead Sponsor JointResearch
Collaborators: OLVG, Uppsala University, Göteborg University, Leiden University Medical Center
Conditions Treatment Outcome
Enrollment 110,000 participants
Start Date 2024-01-08
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-14