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Total joint arthroplasty is one of the best treatment options for end-stage osteoarthritis. Cemented hip arthroplasty is mainly indicated for elderly patients with poor bone quality and multiple comorbidities. Bone cement implantation syndrome is associated with cemented hip arthroplasty and it has been shown to increase cardiovascular and renal complication and brain damage postoperatively. The aim of this project is to elucidate whether remote-ischemic preconditioning (RIPC) has multi-organ protective effect in cemented hip arthroplasty patients.
Total joint arthroplasty is one of the best treatment options for end-stage osteoarthritis. Cemented hip arthroplasty is mainly indicated for elderly patients with poor bone quality and multiple comorbidities. Cemented hip arthroplasty is strongly associated with bone cement implantation syndrome (BCIS). It is characterized by hypoxia, hypotension and/or unexpected loss of consciousness occurring around the time of cementation, prosthesis insertion or reduction of the joint. It has been shown to increase cardiovascular and renal complication and brain damage postoperatively. Remote-ischemic preconditioning has shown kidney, myocardial and brain injury protective effect on non-cardiac surgery patients. The aim of this project is to elucidate whether remote-ischemic preconditioning (RIPC) has multi-organ protective effect in cemented hip arthroplasty patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Sham Comparator | SHAM procedure is done one hour before cemented hip arthroplasty and comprises of 4 cycles of 5min sham procedure. Everything apart from the pressure in the cuff is similar to the RIPC procedure. |
|
| Remote Ischemic preconditioning group | Active Comparator | RIPC procedure is done one hour before cemented hip arthroplasty and comprises of 4 ischemia (using brachial cuff with suprasystolic blood pressure for 5 min) and reperfusion (5 min) cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Ischemic Preconditioning | Procedure | 4 cycles of 5 min pressure (produces an ischemia episode in subject's upper limb) with AutoRIC device (Starfish Medical, Canada) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial injury | Peak hs-cTnT value
| From enrollment to 3. postoperative day |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular injury | Change in baseline of hs-cTnT and NT-proBNP
| From enrollment to 3. postoperative day |
| Clinical serious complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaspar Tootsi, PhD | Contact | +372 7318282 | kaspar.tootsi@kliinikum.ee | |
| Kaarel Ernits, MD | Contact | kaarel.ernits@kliinikum.ee |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tartu | Recruiting | Tartu | Tartu | 50406 | Estonia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40550717 | Derived | Ernits K, Martson A, Kals J, Tagoma A, Maasalu K, Aus A, Vent K, Tootsi K. Remote ischaemic preconditioning in cemented hip arthroplasty (the PRINCIPAL study)-randomised controlled trial: study protocol. BMJ Open. 2025 Jun 23;15(6):e096433. doi: 10.1136/bmjopen-2024-096433. |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D002318 | Cardiovascular Diseases |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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Randomization and intervention is done by a dedicated study nurse. Patient, orthopedic surgeon, investigator and outcomes assessor and statistician are all blinded to the study intervention.
| SHAM | Other | 4 cycles of 5min light pressure (no ischemia produced) with AutoRIC device (Starfish Medical, Canada) to imitate the RIPC procedure |
|
Mortality, Bone cement implantation syndrome, serious cardiovascular complications (heart attack, heart failure, stroke, arrhythmia, peripheral artery thrombosis)
|
| From enrollment to 1 year postoperatively |
| Carotid-femoral pulse velocity | Measured with Sphygmocor XCEL
| From enrollment to 1. postoperative day |
| Augmentation index | Measured with Sphygmocor XCEL
| From enrollment to 1. postoperative day |
| Brain injury | Change in baseline of S-100B and NSE
Change in baseline of Choice-reaction test results done pre-and postoperatively
| From enrollment to 3. postoperative day |
| Kidney Injury | Change in baseline of creatinine and cystatin C
| From enrollment to 3. postoperative day |
| Total antioxidative capacity (TAC) | Change in baseline of total antioxidant capacity (TAC)
| From enrollment to 3. postoperative day |
| Oxidative stress level (total peroxide levels) | Change in baseline total peroxide levels (TPX)
| From enrollment to 3. postoperative day |
| Inflammation level | Change in baseline of inflammation markers (HIF1α, IL6, IL-1β, TNF-α, IL-10)
| From enrollment to 3. postoperative day |
| Low molecular weight metabolites (uM) | Change in baseline of: Acylcarnitines Phosphatidylcholines Lysophosphatidylcholines Sphingomyelins Ceramides Dihydroceramides Hexosylceramides Dihexosylceramides Trihexosylceramides Cholesteryl esters Diglycerides Triglycerides Amino acids Amino acid related Bile acids Biogenic amines Carboxylic acids Fatty acids Hormones Indoles and derivatives | From enrollment to 1. postoperative day |
| D012216 |
| Rheumatic Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |