Lubinus SPII Hip Stem Target Trial Emulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lubinus SPII hip stem 130mm, Lubinus SPII hip stem 150mm.
- Who it may be relevant to
- Registry conditions: Treatment Outcome. Basic parameters: 5 years — 105 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Overview
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.
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
Primary outcome measures
- Mortality rate [Time frame: From date of surgery to date of event (death), minimally 2 years up to 16 years (2007-2023)]
- Revision rate [Time frame: From date of surgery to date of event (revision), minimally 2 years up to 16 years (2007-2023)]
Secondary outcome measures (6)
- NRS pain score [Time frame: before surgery, 3-6 months after surgery, 12 months after surgery]
- Oxford hip score [Time frame: before surgery, 3-6 months after surgery, 12 months after surgery]
- EQ - 5D [Time frame: before surgery, 3-6 months after surgery, 12 months after surgery]
- HOOS - PS [Time frame: before surgery, 3-6 months after surgery, 12 months after surgery]
- Revision rate [Time frame: From date of surgery to date of event (death), minimally 2 years up to 16 years (2007-2023)]
- Mortality rate [Time frame: From date of surgery to date of event (revision), minimally 2 years up to 16 years (2007-2023)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Netherlands · 1 center
- OLVG — Amsterdam
Identifiers
NCT: NCT06367829 · WO.24.025