Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
110000 participants
OBSERVATIONAL
2024-01-08
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Study Groups
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Primary hip replacement patients
Patients who have received primary hip replacement therapy with an indication of osteoarhritis, osteonecrosis or fracture.
Lubinus SPII hip stem 130mm
Shorter length of the SPII hip stem
Lubinus SPII hip stem 150mm
Longer length of the SPII hip stem
Interventions
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Lubinus SPII hip stem 130mm
Shorter length of the SPII hip stem
Lubinus SPII hip stem 150mm
Longer length of the SPII hip stem
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
5 Years
105 Years
ALL
No
Sponsors
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OLVG
NETWORK
Uppsala University
OTHER
Göteborg University
OTHER
Leiden University Medical Center
OTHER
JointResearch
OTHER
Responsible Party
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Principal Investigators
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Rudolf Poolman, Prof. Dr.
Role: STUDY_CHAIR
OLVG
Ariena Rasker, MSc
Role: PRINCIPAL_INVESTIGATOR
Joint research OLVG
Tijs de Koningh
Role: PRINCIPAL_INVESTIGATOR
Joint research OLVG
Locations
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OLVG
Amsterdam, North Holland, Netherlands
Countries
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Other Identifiers
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WO.24.025
Identifier Type: -
Identifier Source: org_study_id
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