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Enrolling by Invitation

NCT Number: NCT06367829

Lubinus SPII Hip Stem 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.

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Key information

Conditions

Treatment Outcome

Age range

5 year–105 year

Sex eligibility

All sexes

Study type

Observational

Primary location

OLVG

Amsterdam, North Holland, 1090 HM, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lubinus SPII hip stem 130mm

Procedure

Shorter length of the SPII hip stem

Other names: 130mm stem

Lubinus SPII hip stem 150mm

Procedure

Longer length of the SPII hip stem

Other names: 150mm stem

Primary outcomes

  1. Mortality rate

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

    Time from primary hip surgery to patient death, per hip stem length

  2. Revision rate

    Time frame: From date of surgery to date of event (revision), minimally 2 years up to 16 years (2007-2023)

    Time from primary hip surgery to implant failure, per hip stem length

Secondary outcomes

  1. NRS pain score

    Time frame: before surgery, 3-6 months after surgery, 12 months after surgery

    pain score for rest and activity, rated 0 - 10 (10 is max pain)

  2. Oxford hip score

    Time frame: before surgery, 3-6 months after surgery, 12 months after surgery

    Hip functionality and pain intensity score , 0 - 60, 60 is max pain/least functionality

  3. EQ - 5D

    Time frame: before surgery, 3-6 months after surgery, 12 months after surgery

    Quality of life measurement based on 5 questions with a score of 0 - 100 (how well does patient experience health, 100 is best)

  4. HOOS - PS

    Time frame: before surgery, 3-6 months after surgery, 12 months after surgery

    Hip functionality, disability and pain test, 5 point liker scale ( 0 - 4), higher score is more functional difficulty

  5. Revision rate

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

    Time from primary hip surgery to implant failure, per cementation type

  6. Mortality rate

    Time frame: From date of surgery to date of event (revision), minimally 2 years up to 16 years (2007-2023)

    Time from primary hip surgery to patient death, per cementation type

Sponsors and collaborators

Lead sponsor

JointResearch

Other

Collaborators

  • Göteborg University
  • Leiden University Medical Center
  • OLVG
  • Uppsala University

Registry information

Official study title

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

Acronym: LARGE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2024
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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