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

University of Tartu

Status: Enrolling

Conditions: Bone Cement Implantation Syndrome; Osteoarthritis, Hip; Kidney Diseases; Cardiovascular Diseases

Treatments: Procedure: Remote Ischemic Preconditioning; Other: SHAM

Study type: Interventional

Funder types: Other

Identifiers

NCT06323018

384T-26

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 65 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

Control group

Sham Comparator group

Description:

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.

Treatment:

Other: SHAM

Remote Ischemic preconditioning group

Active Comparator group

Description:

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.

Treatment:

Procedure: Remote Ischemic Preconditioning