CClinicalTrials.gg
Enrolling by invitationNCT06367829LARGEUpdated May 14, 2026

Lubinus SPII Hip Stem Target Trial Emulation

An observational study in Treatment Outcome, sponsored by JointResearch. Enrolling by invitation at 1 site in Netherlands. Open to participants aged 5 Years to 105 Years. Per ClinicalTrials.gov, last updated 2026-05-14.

Sponsored by JointResearch · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
110,000
Ages
5 Years to 105 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Treatment Outcome
03

In context

Lead sponsor

JointResearch is the lead sponsor of 13 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 105 Years
Sexes eligible
All
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.

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

Exclusion Criteria:

  • Patients who received the Lubinus SPII 150 XL conus stem.
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
110,000 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes

Groups and cohorts

  • 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

  • ProcedureLubinus SPII hip stem 130mm

    Shorter length of the SPII hip stem

    Also known as: 130mm stem

  • ProcedureLubinus SPII hip stem 150mm

    Longer length of the SPII hip stem

    Also known as: 150mm stem

06

What researchers measure

Primary outcomes

  1. Mortality rate

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

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

  2. Revision rate

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

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

Secondary outcomes

  1. NRS pain score

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

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

  2. Oxford hip score

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

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

  3. 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)

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

  4. HOOS - PS

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

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

  5. Revision rate

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

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

  6. Mortality rate

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

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

07

Study locations

1 site
  • OLVG
    Amsterdam, North Holland 1090 HM, Netherlands
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06367829
Lead sponsor
JointResearch
Collaborators
OLVG, Uppsala University, Göteborg University, Leiden University Medical Center
Responsible party
Sponsor
First posted
Apr 16, 2024
Start date
Jan 8, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
May 14, 2026

Study contacts

Rudolf Poolman, Prof. Dr.
study chair · OLVG
Ariena Rasker, MSc
principal investigator · Joint research OLVG
Tijs de Koningh
principal investigator · Joint research OLVG

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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