NCT06323018

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Mar 2024Mar 2027

First Submitted

Initial submission to the registry

March 13, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

March 20, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 21, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Expected
Last Updated

April 4, 2024

Status Verified

April 1, 2024

Enrollment Period

1.9 years

First QC Date

March 13, 2024

Last Update Submit

April 3, 2024

Conditions

Osteoarthritis, HipCardiovascular DiseasesBone Cement Implantation SyndromeKidney Diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (2)

Control group

SHAM COMPARATOR

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

Remote Ischemic preconditioning group

ACTIVE COMPARATOR

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

Interventions

Remote Ischemic PreconditioningPROCEDURE

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

Remote Ischemic preconditioning group
SHAMOTHER

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

Control group

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • age \>65 years
  • undergoing total hip cemented hip arthroplasty

You may not qualify if:

  • previously diagnosed peripheral artery disease on both upper limb
  • RIPC is contraindicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tartu

Tartu, Tartu, 50406, Estonia

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40550717DERIVED

MeSH Terms

Conditions

Osteoarthritis, HipCardiovascular DiseasesKidney Diseases

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Kaspar Tootsi, PhD

CONTACT

+372 7318282kaspar.tootsi@kliinikum.ee

Kaarel Ernits, MD

CONTACT

kaarel.ernits@kliinikum.ee

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 13, 2024

First Posted

March 21, 2024

Study Start

March 20, 2024

Primary Completion

March 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

April 4, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)