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Effects of Remote Ischaemic Preconditioning in Cemented Hip Arthroplasty.

NCT ID: NCT06323018

Last Updated: 2024-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-20

Study Completion Date

2027-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Osteoarthritis, Hip Cardiovascular Diseases Bone Cement Implantation Syndrome Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Randomization and intervention is done by a dedicated study nurse. Patient, orthopedic surgeon, investigator and outcomes assessor and statistician are all blinded to the study intervention.

Study Groups

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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.

Group Type SHAM_COMPARATOR

SHAM

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Remote Ischemic Preconditioning

Intervention Type PROCEDURE

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

Interventions

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Remote Ischemic Preconditioning

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

Intervention Type PROCEDURE

SHAM

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Tartu

OTHER

Sponsor Role lead

Responsible Party

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Kaspar Tootsi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Tartu

Tartu, Tartu, Estonia

Site Status RECRUITING

Countries

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Estonia

Central Contacts

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Kaspar Tootsi, PhD

Role: CONTACT

[email protected]
+372 7318282

Kaarel Ernits, MD

Role: CONTACT

[email protected]

Facility Contacts

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Kaspar Tootsi, MD, PhD

Role: primary

[email protected]
+3727318282

References

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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.

Reference Type DERIVED
PMID: 40550717 (View on PubMed)

Other Identifiers

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384T-26

Identifier Type: -

Identifier Source: org_study_id

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