Treatment OutcomeLARGENCT06367829
Lubinus SPII Hip Stem Target Trial Emulation
An observational study of Treatment Outcome, run by JointResearch at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 105 years
- Conditions the study is for
- Treatment Outcome
- What is being tested?
- Lubinus SPII hip stem 130mm and Lubinus SPII hip stem 150mm
- Type of treatment
- Surgery or procedure
- How many people
- 110,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Jan 2024to 31 Dec 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 105 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- Patients who received the Lubinus SPII 150 XL conus stem.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
The research questions this study aims to answer are as follows:
Primary research question:
Read more
"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
- Being tested
- Lubinus SPII hip stem 130mm, Lubinus SPII hip stem 150mm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lubinus SPII hip stem 130mmProcedure or surgery
Also called 130mm stem
Shorter length of the SPII hip stem
Lubinus SPII hip stem 150mmProcedure or surgery
Also called 150mm stem
Longer length of the SPII hip stem
| Study group | Role | What they receive |
|---|---|---|
| Primary hip replacement patients | Patients who have received primary hip replacement therapy with an indication of osteoarhritis, osteonecrosis or fracture. Receives: Procedure: Lubinus SPII hip stem 130mm; Procedure: Lubinus SPII hip stem 150mm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
Time from primary hip surgery to patient death, per hip stem length
Measured: 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
Measured: From date of surgery to date of event (revision), minimally 2 years up to 16 years (2007-2023)
Secondary outcomes (6)
NRS pain score
pain score for rest and activity, rated 0 - 10 (10 is max pain)
Measured: 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
Measured: 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)
Measured: 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
Measured: before surgery, 3-6 months after surgery, 12 months after surgery
Revision rate
Time from primary hip surgery to implant failure, per cementation type
Measured: 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
Measured: From date of surgery to date of event (revision), minimally 2 years up to 16 years (2007-2023)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start8 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment OutcomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 110,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- JointResearch
- Sponsor type
- University, hospital or other
- Collaborators
- OLVG, Uppsala University, Göteborg University, Leiden University Medical Center
- Responsible party
- Sponsor
- Investigators
- Rudolf Poolman, Prof. Dr., Study chair, OLVGAriena Rasker, MSc, Principal investigator, Joint research OLVGTijs de Koningh, Principal investigator, Joint research OLVG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367829
- Sponsor's protocol ID
- WO.24.025
- Acronym
- LARGE
- Status last verified
- May 2026
- First submitted
- 4 Apr 2024
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06367829
- Acronym / sponsor ID
- LARGE / WO.24.025
- Conditions
- Treatment Outcome
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 110,000 participants (estimated)
- Lead sponsor
- JointResearchUniversity, hospital or other
- Collaborators
- OLVG, Uppsala University, Göteborg University, Leiden University Medical Center
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary hip replacement patients | – | Procedure: Lubinus SPII hip stem 130mm, Procedure: Lubinus SPII hip stem 150mmPatients who have received primary hip replacement therapy with an indication of osteoarhritis, osteonecrosis or fracture. |
Who may qualify
- Ages
- 5 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Listed in registry for primary hip arthroplasty.
Key exclusion criteria (1 listed)
- Patients who received the Lubinus SPII 150 XL conus stem.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lubinus SPII hip stem 130mmAlso: 130mm stemShorter length of the SPII hip stem | Procedure or surgery | Primary hip replacement patients |
| Lubinus SPII hip stem 150mmAlso: 150mm stemLonger length of the SPII hip stem | Procedure or surgery | Primary hip replacement patients |
Primary outcome
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
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
6 secondary outcomes
NRS pain score
Time frame: before surgery, 3-6 months after surgery, 12 months after surgery
Oxford hip score
Time frame: before surgery, 3-6 months after surgery, 12 months after surgery
EQ - 5D
Time frame: before surgery, 3-6 months after surgery, 12 months after surgery
HOOS - PS
Time frame: before surgery, 3-6 months after surgery, 12 months after surgery
Revision rate
Time frame: From date of surgery to date of event (death), minimally 2 years up to 16 years (2007-2023)
Mortality rate
Time frame: From date of surgery to date of event (revision), minimally 2 years up to 16 years (2007-2023)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rudolf Poolman, Prof. Dr. study chair
OLVG
Ariena Rasker, MSc principal investigator
Joint research OLVG
Tijs de Koningh principal investigator
Joint research OLVG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Treatment Outcome, run by JointResearch at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate (time frame: From date of surgery to date of event (death), minimally 2 years up to 16 years (2007-2023)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.