Lubinus SPII Hip Stem Target Trial Emulation (LARGE)

JointResearch

Status

Invitation-only

Conditions

Treatment Outcome

Treatments

Procedure: Lubinus SPII hip stem 130mm

Procedure: Lubinus SPII hip stem 150mm

Study type

Observational

Funder types

Other

NETWORK

Identifiers

NCT06367829

WO.24.025

Details and patient eligibility

About

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.

Enrollment

110,000 estimated patients

Sex

All

Ages

5 to 105 years old

Volunteers

No Healthy Volunteers

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