Treatment Outcome
Conditions
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.
Interventions
PROCEDURELubinus SPII hip stem 150mm
Longer length of the SPII hip stem
PROCEDURELubinus SPII hip stem 130mm
Shorter length of the SPII hip stem
Sponsors
JointResearch
OLVG
Uppsala University
Göteborg University
Leiden University Medical Center
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
5 Years to 105 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality rate | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| NRS pain score | before surgery, 3-6 months after surgery, 12 months after surgery | pain score for rest and activity, rated 0 - 10 (10 is max pain) |
| Oxford hip score | 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 |
| EQ - 5D | 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) |
| HOOS - PS | 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 |
| Revision rate | 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 |
| Mortality rate | 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 |
Countries
Netherlands
Contacts
STUDY_CHAIRRudolf Poolman, Prof. Dr.
OLVG
PRINCIPAL_INVESTIGATORAriena Rasker, MSc
Joint research OLVG
PRINCIPAL_INVESTIGATORTijs de Koningh
Joint research OLVG
Outcome results
None listed