Lubinus SPII Hip Stem Target Trial Emulation (LARGE)

Comparing Mortality, Revision Rates, and Patient-Reported Outcomes With Different Stem Lengths of the Lubinus SPII Cemented Hip Stem: A Target Trial Emulation.

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Treatment Outcome
• Intervention / Treatment: Procedure: Lubinus SPII hip stem 130mm; Procedure: Lubinus SPII hip stem 150mm

• Study Type: Observational
• Enrollment (Estimated): 110000

Contacts and Locations

Study Locations

• Netherlands
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1090 HM
      • OLVG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Primary hip replacement patients; Patients who have received primary hip replacement therapy with an indication of osteoarhritis, osteonecrosis or fracture.	Procedure: Lubinus SPII hip stem 130mm; Shorter length of the SPII hip stem; Other Names: 130mm stem; Procedure: Lubinus SPII hip stem 150mm; Longer length of the SPII hip stem; Other Names: 150mm stem

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality rate	Time from primary hip surgery to patient death, per hip stem length	From date of surgery to date of event (death), minimally 2 years up to 16 years (2007-2023)
Revision rate	Time from primary hip surgery to implant failure, per hip stem length	From date of surgery to date of event (revision), minimally 2 years up to 16 years (2007-2023)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS pain score	pain score for rest and activity, rated 0 - 10 (10 is max pain)	before surgery, 3-6 months after surgery, 12 months after surgery
Oxford hip score	Hip functionality and pain intensity score , 0 - 60, 60 is max pain/least functionality	before surgery, 3-6 months after surgery, 12 months after surgery
EQ - 5D	Quality of life measurement based on 5 questions with a score of 0 - 100 (how well does patient experience health, 100 is best)	before surgery, 3-6 months after surgery, 12 months after surgery
HOOS - PS	Hip functionality, disability and pain test, 5 point liker scale ( 0 - 4), higher score is more functional difficulty	before surgery, 3-6 months after surgery, 12 months after surgery
Revision rate	Time from primary hip surgery to implant failure, per cementation type	From date of surgery to date of event (death), minimally 2 years up to 16 years (2007-2023)
Mortality rate	Time from primary hip surgery to patient death, per cementation type	From date of surgery to date of event (revision), minimally 2 years up to 16 years (2007-2023)

Collaborators and Investigators

• Sponsor: JointResearch
• Collaborators: Uppsala University; Göteborg University; Leiden University Medical Center; OLVG
• Investigators: Study Chair: Rudolf Poolman, Prof. Dr., OLVG; Principal Investigator: Ariena Rasker, MSc, Joint research OLVG; Principal Investigator: Tijs de Koningh, Joint research OLVG

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Microscopy; Microscopy, Electron, Transmission; Microscopy, Electron; Microscopy, Electron, Scanning Transmission
• Other Study ID Numbers: WO.24.025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No