NCT06323018|RecruitingDMC
Effects of Remote Ischaemic Preconditioning in Cemented Hip Arthroplasty.
PRINCIPAL
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PRINCIPAL
Sponsor study identifier
interventional
200
1 country
1
Study Start
March 20, 2024
Actual (reported)Primary Completion
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 13, 2024
Actual (reported)March 20, 2024
Actual (reported)March 21, 2024
Actual (reported)March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Cardiovascular injury
From enrollment to 3. postoperative day
Clinical serious complications
From enrollment to 1 year postoperatively
Carotid-femoral pulse velocity
From enrollment to 1. postoperative day
Augmentation index
From enrollment to 1. postoperative day
Brain injury
From enrollment to 3. postoperative day
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.
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.
4 cycles of 5 min pressure (produces an ischemia episode in subject's upper limb) with AutoRIC device (Starfish Medical, Canada)
4 cycles of 5min light pressure (no ischemia produced) with AutoRIC device (Starfish Medical, Canada) to imitate the RIPC procedure
University of Tartu
Tartu, Tartu, 50406, Estonia
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.
First Submitted
March 13, 2024
First Posted
March 21, 2024
Study Start
March 20, 2024
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 4, 2024
Record last verified: 2024-04
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Source: ClinicalTrials.gov.
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