Lubinus SPII Hip Stem Target Trial Emulation (LARGE)

Launched by JOINTRESEARCH · Apr 10, 2024

Keywords

ClinConnect Summary

This is a large observational study that looks at two different lengths of a cemented hip stem (130 mm vs 150 mm) used in primary total hip replacement for people with osteoarthritis, hip fracture, or osteonecrosis. The researchers want to know if the longer 150 mm stem leads to different outcomes than the 130 mm stem, specifically in how long the implant lasts before needing another operation (revision) and how long people live after their hip surgery. They will also examine secondary outcomes like pain levels, hip function, and quality of life, and they will consider how the way the stem is cemented in place might affect results. The study will use data from Dutch and Swedish hip-implant registries and is expected to include about 110,000 patients who had these procedures between 2007 and 2020.

Who might be eligible and what to expect: people who had a primary hip replacement with the Lubinus SPII stem (either 130 mm or 150 mm) for osteoarthritis, osteonecrosis, or a hip fracture, and who have end-point information in the registries (alive, deceased, or revision). The study does not assign people to a stem length or change their care; it analyzes existing registry data. It includes patients roughly from age 5 up to 105 and excludes the 150 mm XL conus stem. Enrollment began in January 2024 and is by invitation, with an estimated completion by December 2025. The study is not designed to share individual patient data, and it involves several international collaborators, including centers in the Netherlands and Sweden.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Listed in registry for primary hip arthroplasty.
• • Listed in registry with an indication of osteoarthritis, osteonecrosis or hip fracture.
• • Received the Lubinus SPII hip stem, 130mm or 150mm, for their primary hip arthro- plasty.
• • End point listed in registry (Alive, Deceased or revision).
• Exclusion Criteria:
• • Patients who received the Lubinus SPII 150 XL conus stem.