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Effects of Remote Ischaemic Preconditioning in Cemented Hip Arthroplasty.

ConditionsOsteoarthritis, HipCardiovascular DiseasesBone Cement Implantation SyndromeKidney Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-90
SponsorUniversity of Tartu

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age >65 years

undergoing total hip cemented hip arthroplasty

Disqualifiers

previously diagnosed peripheral artery disease on both upper limb

RIPC is contraindicated

Trial design

Design model

Parallel

Treatments tested in this trial

  • Remote Ischemic Preconditioning

    Procedure/Surgery

    4 cycles of 5 min pressure (produces an ischemia episode in subject's upper limb) with AutoRIC device (Starfish Medical, Canada)

  • SHAM

    Other intervention

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Control groupSham comparator 1 intervention
Group B: Remote Ischemic preconditioning groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Myocardial injury

Peak hs-cTnT value * baseline characteristics are measured before surgery * measuring is repeated 1h after surgery and up to 3 days postoperatively

Time frame
From enrollment to 3. postoperative day

Secondary outcomes

1

Cardiovascular injury

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)

Time frame
From enrollment to 3. postoperative day
2

Clinical serious complications

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

Time frame
From enrollment to 1 year postoperatively
3

Carotid-femoral pulse velocity

Measured with Sphygmocor XCEL * baseline characteristics are measured before surgery * measuring is repeated 24 h after surgery

Time frame
From enrollment to 1. postoperative day
4

Augmentation index

Measured with Sphygmocor XCEL * baseline characteristics are measured before surgery * measuring is repeated 24 h after surgery

Time frame
From enrollment to 1. postoperative day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Tartu

Lead sponsor

Source ClinicalTrials.gov
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