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NCT06323018 | RECRUITING | Osteoarthritis, Hip


Effects of Remote Ischaemic Preconditioning in Cemented Hip Arthroplasty.
Sponsor:

University of Tartu

Information provided by (Responsible Party):

Kaspar Tootsi

Brief Summary:

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.

Condition or disease

Osteoarthritis, Hip

Cardiovascular Diseases

Bone Cement Implantation Syndrome

Kidney Diseases

Intervention/treatment

Remote Ischemic Preconditioning

SHAM

Phase

NA

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
Estimated Enrollment : 200 participants
Masking : QUADRUPLE
Masking Description : 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.
Primary Purpose : PREVENTION
Official Title : Effects of Remote Ischaemic Preconditioning in Cemented Total Hip Arthroplasty: Randomized Controlled Trial
Actual Study Start Date : 2024-03-20
Estimated Primary Completion Date : 2026-03
Estimated Study Completion Date : 2027-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 65 Years to 90 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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

Effects of Remote Ischaemic Preconditioning in Cemented Hip Arthroplasty.

Location Details

NCT06323018


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Locations


RECRUITING

Estonia, Tartu

University of Tartu

Tartu, Tartu, Estonia, 50406

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