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Recruiting NCT06323018

Effects of Remote Ischaemic Preconditioning in Cemented Hip Arthroplasty.

No phase Interventional Osteoarthritis, Hip Cardiovascular Diseases Bone Cement Implantation Syndrome Kidney Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Remote Ischemic Preconditioning, SHAM.
Who it may be relevant to
Registry conditions: Osteoarthritis, Hip, Cardiovascular Diseases, Bone Cement Implantation Syndrome, Kidney Diseases. Basic parameters: 65 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Estonia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effects of Remote Ischaemic Preconditioning in Cemented Total Hip Arthroplasty: Randomized Controlled Trial

Overview

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.

Interventions

  • Procedure Remote Ischemic Preconditioning
    4 cycles of 5 min pressure (produces an ischemia episode in subject's upper limb) with AutoRIC device (Starfish Medical, Canada)
  • Other SHAM
    4 cycles of 5min light pressure (no ischemia produced) with AutoRIC device (Starfish Medical, Canada) to imitate the RIPC procedure

Primary outcome measures

  • Myocardial injury [Time frame: From enrollment to 3. postoperative day]
Secondary outcome measures (10)
  • Cardiovascular injury [Time frame: From enrollment to 3. postoperative day]
  • Clinical serious complications [Time frame: From enrollment to 1 year postoperatively]
  • Carotid-femoral pulse velocity [Time frame: From enrollment to 1. postoperative day]
  • Augmentation index [Time frame: From enrollment to 1. postoperative day]
  • Brain injury [Time frame: From enrollment to 3. postoperative day]
  • Kidney Injury [Time frame: From enrollment to 3. postoperative day]
  • Total antioxidative capacity (TAC) [Time frame: From enrollment to 3. postoperative day]
  • Oxidative stress level (total peroxide levels) [Time frame: From enrollment to 3. postoperative day]
  • Inflammation level [Time frame: From enrollment to 3. postoperative day]
  • Low molecular weight metabolites (uM) [Time frame: From enrollment to 1. postoperative day]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Estonia · 1 center
  • University of Tartu — Tartu

Publications

  • 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. PMID 40550717

Identifiers

NCT: NCT06323018 · 384T-26

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗