Lubinus SPII Hip Stem Target Trial Emulation (LARGE)

NCT06367829 | Enrolling By Invitation

• 1 other identifier: WO.24.025
• Study Type: observational
• Target: 110,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatment Outcome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• NRS pain score

  before surgery, 3-6 months after surgery, 12 months after surgery

• Oxford hip score

  before surgery, 3-6 months after surgery, 12 months after surgery

• EQ - 5D

  before surgery, 3-6 months after surgery, 12 months after surgery

• HOOS - PS

  before surgery, 3-6 months after surgery, 12 months after surgery

• Revision rate

  From date of surgery to date of event (death), minimally 2 years up to 16 years (2007-2023)

Study Arms (1)

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; Procedure: Lubinus SPII hip stem 150mm

Interventions

Lubinus SPII hip stem 130mm PROCEDURE

Shorter length of the SPII hip stem

Also known as: 130mm stem

Primary hip replacement patients

Lubinus SPII hip stem 150mm PROCEDURE

Longer length of the SPII hip stem

Also known as: 150mm stem

Primary hip replacement patients

Eligibility Criteria

• Age: 5 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• Patients who received the Lubinus SPII 150 XL conus stem.

Sponsors & Collaborators

• JointResearch: lead
• OLVG: collaborator
• Uppsala University: collaborator
• Göteborg University: collaborator
• Leiden University Medical Center: collaborator

Study Sites (1)

OLVG

Amsterdam, North Holland, 1090 HM, Netherlands

Location

MeSH Terms

Interventions

Microscopy, Electron, Scanning Transmission

Intervention Hierarchy (Ancestors)

Microscopy, Electron, Transmission; Microscopy, Electron; Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Rudolf Poolman, Prof. Dr.

  OLVG

  STUDY CHAIR

• Ariena Rasker, MSc

  Joint research OLVG

  PRINCIPAL INVESTIGATOR

• Tijs de Koningh

  Joint research OLVG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 16, 2024
• Study Start: January 8, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)