Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06367829
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-16
First Post:
2024-04-04
Brief Title:
Lubinus SPII Hip Stem Target Trial Emulation LARGE
Sponsor:
JointResearch
Organization:
JointResearch
Study Overview
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
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LARGE
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None