Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06323018

Effects of Remote Ischaemic Preconditioning in Cemented Hip Arthroplasty.

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Osteoarthritis, Hip Arthritis Bone Cement Implantation Syndrome Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Joint Diseases Kidney Diseases Male Urogenital Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases Urogenital Diseases Urologic Diseases

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Tartu

Tartu, 50406, Estonia

Location status: Recruiting

Location contact

Kaspar Tootsi, MD, PhD

CONTACT

[email protected]

+3727318282

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

SHAM

Other

4 cycles of 5min light pressure (no ischemia produced) with AutoRIC device (Starfish Medical, Canada) to imitate the RIPC procedure

Primary outcomes

  1. Myocardial injury

    Time frame: From enrollment to 3. postoperative day

    Peak hs-cTnT value

    • baseline characteristics are measured before surgery
    • measuring is repeated 1h after surgery and up to 3 days postoperatively

Secondary outcomes

  1. Cardiovascular injury

    Time frame: From enrollment to 3. postoperative day

    Change in baseline of hs-cTnT and NT-proBNP

    • baseline characteristics are measured before surgery
    • measurements are repeated 1h after surgery and up to 3 days postoperatively (once a day)

  2. Clinical serious complications

    Time frame: From enrollment to 1 year postoperatively

    Mortality, Bone cement implantation syndrome, serious cardiovascular complications (heart attack, heart failure, stroke, arrhythmia, peripheral artery thrombosis)

    • data is collected trough Estonian National Health database "Digilugu"
    • blood pressure, saturation and patient's mental state are monitored during the operation to register any case of bone cement implantation syndrome

  3. Carotid-femoral pulse velocity

    Time frame: From enrollment to 1. postoperative day

    Measured with Sphygmocor XCEL

    • baseline characteristics are measured before surgery
    • measuring is repeated 24 h after surgery

  4. Augmentation index

    Time frame: From enrollment to 1. postoperative day

    Measured with Sphygmocor XCEL

    • baseline characteristics are measured before surgery
    • measuring is repeated 24 h after surgery

  5. Brain injury

    Time frame: From enrollment to 3. postoperative day

    Change in baseline of S-100B and NSE

    • baseline characteristics are measured before surgery
    • measuring is repeated 1h after surgery and up to 3 days postoperatively

    Change in baseline of Choice-reaction test results done pre-and postoperatively

    • baseline test result is measured before surgery
    • measuring is repeated 24h after surgery

  6. Kidney Injury

    Time frame: From enrollment to 3. postoperative day

    Change in baseline of creatinine and cystatin C

    • baseline characteristics are measured before surgery
    • measuring is repeated 1h after surgery and up to 3 days postoperatively

  7. Total antioxidative capacity (TAC)

    Time frame: From enrollment to 3. postoperative day

    Change in baseline of total antioxidant capacity (TAC)

    • baseline characteristics are measured before surgery
    • measuring is repeated 1h after surgery and up to 3 days postoperatively

  8. Oxidative stress level (total peroxide levels)

    Time frame: From enrollment to 3. postoperative day

    Change in baseline total peroxide levels (TPX)

    • baseline characteristics are measured before surgery
    • measuring is repeated 1h after surgery and up to 3 days postoperatively

  9. Inflammation level

    Time frame: From enrollment to 3. postoperative day

    Change in baseline of inflammation markers (HIF1α, IL6, IL-1β, TNF-α, IL-10)

    • baseline characteristics are measured before surgery
    • measuring is repeated 1h after surgery and on the first postoperative day

  10. Low molecular weight metabolites (uM)

    Time frame: From enrollment to 1. postoperative day

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Kaarel Ernits, MD

CONTACT

[email protected]

Kaspar Tootsi, PhD

CONTACT

[email protected]

+372 7318282

Sponsors and collaborators

Lead sponsor

University of Tartu

Other

Registry information

Official study title

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

Acronym: PRINCIPAL

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 21, 2024
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.