Clinical trial NCT06367829: Lubinus SPII Hip Stem Target Trial Emulation (LARGE)
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.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Treatment Outcome
Lead sponsor: JointResearch
Sponsor class: OTHER
Collaborators: name: OLVG
name: Uppsala University
name: Göteborg University
name: Leiden University Medical Center
First posted: 2024-04-16
Enrollment: 110000
Sex: ALL
Minimum age (years): 5
Maximum age (years): 105
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All patients incorporated in the LROI and SAR databases between 2007 and 2020 were included, if they satisfied the in- and exclusion criteria.

Brief 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.


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.

Primary outcomes:
measure: Mortality rate
timeFrame: From date of surgery to date of event (death), minimally 2 years up to 16 years (2007-2023)
measure: Revision rate
timeFrame: From date of surgery to date of event (revision), minimally 2 years up to 16 years (2007-2023)
Secondary outcomes:
measure: NRS pain score
timeFrame: before surgery, 3-6 months after surgery, 12 months after surgery
measure: Oxford hip score
timeFrame: before surgery, 3-6 months after surgery, 12 months after surgery
measure: EQ - 5D
timeFrame: before surgery, 3-6 months after surgery, 12 months after surgery
measure: HOOS - PS
timeFrame: before surgery, 3-6 months after surgery, 12 months after surgery
measure: Revision rate
timeFrame: From date of surgery to date of event (death), minimally 2 years up to 16 years (2007-2023)
measure: Mortality rate
timeFrame: From date of surgery to date of event (revision), minimally 2 years up to 16 years (2007-2023)
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: OLVG
state: Noord Holland
Study officials:
affiliation: OLVG
name: Rudolf Poolman, Prof. Dr.
role: STUDY_CHAIR
affiliation: Joint research OLVG
name: Ariena Rasker, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Joint research OLVG
name: Tijs de Koningh
role: PRINCIPAL_INVESTIGATOR
References: