Clinical trial NCT06323018: Effects of Remote Ischaemic Preconditioning in Cemented Hip Arthroplasty.
Official title: Effects of Remote Ischaemic Preconditioning in Cemented Total Hip Arthroplasty: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Hip
Cardiovascular Diseases
Bone Cement Implantation Syndrome
Kidney Diseases
Lead sponsor: University of Tartu
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* age \>65 years
* undergoing total hip cemented hip arthroplasty

Exclusion Criteria:

* previously diagnosed peripheral artery disease on both upper limb
* RIPC is contraindicated

Primary outcomes:
measure: Myocardial injury
timeFrame: From enrollment to 3. postoperative day
Secondary outcomes:
measure: Cardiovascular injury
timeFrame: From enrollment to 3. postoperative day
measure: Clinical serious complications
timeFrame: From enrollment to 1 year postoperatively
measure: Carotid-femoral pulse velocity
timeFrame: From enrollment to 1. postoperative day
measure: Augmentation index
timeFrame: From enrollment to 1. postoperative day
measure: Brain injury
timeFrame: From enrollment to 3. postoperative day
measure: Kidney Injury
timeFrame: From enrollment to 3. postoperative day
measure: Total antioxidative capacity (TAC)
timeFrame: From enrollment to 3. postoperative day
measure: Oxidative stress level (total peroxide levels)
timeFrame: From enrollment to 3. postoperative day
measure: Inflammation level
timeFrame: From enrollment to 3. postoperative day
measure: Low molecular weight metabolites (uM)
timeFrame: From enrollment to 1. postoperative day
Other outcomes:
Locations:
city: Tartu
country: Estonia
facility: University of Tartu
state: Tartumaa
Study officials:
References: