Remote ischaemic preconditioning in cemented hip arthroplasty (the PRINCIPAL study)—randomised controlled trial: study protocol
Introduction Total hip arthroplasty (THA) is an effective treatment for severe osteoarthritis. However, THA has a high surgical risk for patients with concomitant diseases and is associated with several serious complications, such as myocardial infarction, acute kidney injury and cognitive dysfuncti...
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BMJ Publishing Group
2025-06-01
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| author | Jaak Kals Aare Martson Kaarel Ernits Aili Tagoma Katre Maasalu Anneli Aus Kristi Vent Kaspar Tootsi |
| author_facet | Jaak Kals Aare Martson Kaarel Ernits Aili Tagoma Katre Maasalu Anneli Aus Kristi Vent Kaspar Tootsi |
| author_sort | Jaak Kals |
| collection | DOAJ |
| description | Introduction Total hip arthroplasty (THA) is an effective treatment for severe osteoarthritis. However, THA has a high surgical risk for patients with concomitant diseases and is associated with several serious complications, such as myocardial infarction, acute kidney injury and cognitive dysfunction. This study will explore the potential protective effects of remote ischaemic preconditioning (RIPC) in cemented THA patients.Methods and analysis The PRINCIPAL study is designed as a randomised, controlled, parallel-group, blinded trial to assess the impact of RIPC in cemented THA patients. The study will compare two patient groups—one group will have the RIPC procedure, and the second will have the sham procedure. The primary outcome is the peak troponin T concentration during the three postoperative days. Secondary outcomes include markers of arterial stiffness (augmentation index (AIx), carotid-femoral pulse wave velocity, central blood pressures), neural (neuron-specific enolase, S100B) and renal injury biomarkers (estimated glomerular filtration rate, creatinine, cystatin C), markers of systemic inflammation (hypoxia-inducible factor 1-alpha, interleukin (IL)-6, IL-1β, tumour necrosis factor-alpha, IL-10) and oxidative stress (total peroxide concentration, total antioxidant capacity), as well as clinical outcome measures such as major adverse cardiovascular events and all-cause mortality.Ethics and dissemination The ethical board of the University of Tartu has granted approval for the study (no. 384T-26). The results of this study will be disseminated in international peer-reviewed journals.Trial registration number NCT06323018. |
| format | Article |
| id | doaj-art-95a7b05c5dd045bbb3c44206a71c4f35 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-95a7b05c5dd045bbb3c44206a71c4f352025-08-20T02:22:09ZengBMJ Publishing GroupBMJ Open2044-60552025-06-0115610.1136/bmjopen-2024-096433Remote ischaemic preconditioning in cemented hip arthroplasty (the PRINCIPAL study)—randomised controlled trial: study protocolJaak Kals0Aare Martson1Kaarel Ernits2Aili Tagoma3Katre Maasalu4Anneli Aus5Kristi Vent6Kaspar Tootsi7Endothelial Centre, University of Tartu, Tartu, EstoniaDepartment of Orthopaedics, Institute of Clinical Medicine, University of Tartu, Tartu, EstoniaDepartment of Orthopaedics, Institute of Clinical Medicine, University of Tartu, Tartu, EstoniaDepartment of Immunology, Institute of Biomedicine and Translational Medicine, University of Tartu, Tartu, EstoniaDepartment of Orthopaedics, Institute of Clinical Medicine, University of Tartu, Tartu, EstoniaUnited Laboratories, Tartu University Hospital, Tartu, EstoniaClinic of Orthopaedics, Tartu University Hospital, Tartu, EstoniaDepartment of Orthopaedics, Institute of Clinical Medicine, University of Tartu, Tartu, EstoniaIntroduction Total hip arthroplasty (THA) is an effective treatment for severe osteoarthritis. However, THA has a high surgical risk for patients with concomitant diseases and is associated with several serious complications, such as myocardial infarction, acute kidney injury and cognitive dysfunction. This study will explore the potential protective effects of remote ischaemic preconditioning (RIPC) in cemented THA patients.Methods and analysis The PRINCIPAL study is designed as a randomised, controlled, parallel-group, blinded trial to assess the impact of RIPC in cemented THA patients. The study will compare two patient groups—one group will have the RIPC procedure, and the second will have the sham procedure. The primary outcome is the peak troponin T concentration during the three postoperative days. Secondary outcomes include markers of arterial stiffness (augmentation index (AIx), carotid-femoral pulse wave velocity, central blood pressures), neural (neuron-specific enolase, S100B) and renal injury biomarkers (estimated glomerular filtration rate, creatinine, cystatin C), markers of systemic inflammation (hypoxia-inducible factor 1-alpha, interleukin (IL)-6, IL-1β, tumour necrosis factor-alpha, IL-10) and oxidative stress (total peroxide concentration, total antioxidant capacity), as well as clinical outcome measures such as major adverse cardiovascular events and all-cause mortality.Ethics and dissemination The ethical board of the University of Tartu has granted approval for the study (no. 384T-26). The results of this study will be disseminated in international peer-reviewed journals.Trial registration number NCT06323018.https://bmjopen.bmj.com/content/15/6/e096433.full |
| spellingShingle | Jaak Kals Aare Martson Kaarel Ernits Aili Tagoma Katre Maasalu Anneli Aus Kristi Vent Kaspar Tootsi Remote ischaemic preconditioning in cemented hip arthroplasty (the PRINCIPAL study)—randomised controlled trial: study protocol BMJ Open |
| title | Remote ischaemic preconditioning in cemented hip arthroplasty (the PRINCIPAL study)—randomised controlled trial: study protocol |
| title_full | Remote ischaemic preconditioning in cemented hip arthroplasty (the PRINCIPAL study)—randomised controlled trial: study protocol |
| title_fullStr | Remote ischaemic preconditioning in cemented hip arthroplasty (the PRINCIPAL study)—randomised controlled trial: study protocol |
| title_full_unstemmed | Remote ischaemic preconditioning in cemented hip arthroplasty (the PRINCIPAL study)—randomised controlled trial: study protocol |
| title_short | Remote ischaemic preconditioning in cemented hip arthroplasty (the PRINCIPAL study)—randomised controlled trial: study protocol |
| title_sort | remote ischaemic preconditioning in cemented hip arthroplasty the principal study randomised controlled trial study protocol |
| url | https://bmjopen.bmj.com/content/15/6/e096433.full |
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