NCT06367829

Lubinus SPII Hip Stem Target Trial Emulation (LARGE)

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 110,000 (estimated)
• Sponsor: JointResearch · Academic / Other
• Sex: All
• Age: 5 Years – 105 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2024-01-08
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-04-16
• Last updated: 2025-11-18

Locations

1 site across 1 country: Netherlands