Effects of Remote Ischaemic Preconditioning in Cemented Hip Arthroplasty. (PRINCIPAL)

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

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Kidney Diseases; Osteoarthritis, Hip; Bone Cement Implantation Syndrome
• Intervention / Treatment: Other: SHAM; Procedure: Remote Ischemic Preconditioning

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kaspar Tootsi, PhD; Phone Number: +372 7318282; Email: kaspar.tootsi@kliinikum.ee
• Study Contact Backup: Name: Kaarel Ernits, MD; Email: kaarel.ernits@kliinikum.ee

Study Locations

• Estonia
  • Tartumaa
    • Tartu, Tartumaa, Estonia, 50406
      • Recruiting
      • University of Tartu
      • Contact: Kaspar Tootsi, MD, PhD; Phone Number: +3727318282; Email: kaspar.tootsi@kliinikum.ee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control group; 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.	Other: SHAM; 4 cycles of 5min light pressure (no ischemia produced) with AutoRIC device (Starfish Medical, Canada) to imitate the RIPC procedure
Active Comparator: Remote Ischemic preconditioning group; 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.	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial injury	Peak hs-cTnT value; baseline characteristics are measured before surgery; measuring is repeated 1h after surgery and up to 3 days postoperatively	From enrollment to 3. postoperative day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	From enrollment to 3. postoperative day
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	From enrollment to 1 year postoperatively
Carotid-femoral pulse velocity	Measured with Sphygmocor XCEL; baseline characteristics are measured before surgery; measuring is repeated 24 h after surgery	From enrollment to 1. postoperative day
Augmentation index	Measured with Sphygmocor XCEL; baseline characteristics are measured before surgery; measuring is repeated 24 h after surgery	From enrollment to 1. postoperative day
Brain injury	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	From enrollment to 3. postoperative day
Kidney Injury	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	From enrollment to 3. postoperative day
Total antioxidative capacity (TAC)	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	From enrollment to 3. postoperative day
Oxidative stress level (total peroxide levels)	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	From enrollment to 3. postoperative day
Inflammation level	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	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

Collaborators and Investigators

• Sponsor: University of Tartu

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Cardiovascular Diseases; Kidney Diseases; Osteoarthritis, Hip
• Other Study ID Numbers: 384T-26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No