Lubinus SPII Hip Stem Target Trial Emulation (LARGE)

Treatment Outcome Clinical Trial

— LARGE  

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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06367829
• Other study ID #: WO.24.025
• Status: Enrolling by invitation
• Start date: January 8, 2024
• Est. completion date: January 8, 2025

Study information

• Verified date: April 2024
• Source: JointResearch
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 110000
• Est. completion date: January 8, 2025
• Est. primary completion date: July 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 105 Years

Eligibility

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.

Related Conditions & MeSH terms

• Treatment Outcome

Intervention

Procedure:
• Lubinus SPII hip stem 130mm
Shorter length of the SPII hip stem
• Lubinus SPII hip stem 150mm
Longer length of the SPII hip stem

Locations

Country	Name	City	State
Netherlands	OLVG	Amsterdam	Noord Holland

Sponsors (5)

Lead Sponsor	Collaborator
JointResearch	Göteborg University, Leiden University Medical Center, OLVG, Uppsala University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)