Osteoarthritis, HipPRINCIPALNCT06323018
Effects of Remote Ischaemic Preconditioning in Cemented Hip Arthroplasty.
A study testing Remote Ischemic Preconditioning in people with Osteoarthritis, Hip and Cardiovascular Diseases, run by University of Tartu at 1 site in Estonia.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Osteoarthritis, Hip, Cardiovascular Diseases, Bone Cement Implantation Syndrome
- What is being tested?
- Remote Ischemic Preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteEstonia
- Study dates
- 20 Mar 2024to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age >65 years
- undergoing total hip cemented hip arthroplasty
Who cannot join
- previously diagnosed peripheral artery disease on both upper limb
- RIPC is contraindicated
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kaarel Ernits, MD contact
Estonia1 site, 1 recruiting
- Recruiting
University of Tartu
Tartu, Tartu, 50406
Kaspar Tootsi, MD, PhD, +3727318282, kaspar.tootsi@kliinikum.ee
About this study
Official title: Effects of Remote Ischaemic Preconditioning in Cemented Total Hip Arthroplasty: Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Osteoarthritis, Hip, Cardiovascular Diseases, Bone Cement Implantation Syndrome, Kidney Diseases
- Being tested
- Remote Ischemic Preconditioning, SHAM
- Medical subject headings
- Osteoarthritis, Hip, Cardiovascular Diseases, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischemic PreconditioningProcedure or surgery
4 cycles of 5 min pressure (produces an ischemia episode in subject's upper limb) with AutoRIC device (Starfish Medical, Canada)
SHAMOther
4 cycles of 5min light pressure (no ischemia produced) with AutoRIC device (Starfish Medical, Canada) to imitate the RIPC procedure
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Remote Ischemic Preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial injury
Peak hs-cTnT value
- baseline characteristics are measured before surgery
- measuring is repeated 1h after surgery and up to 3 days postoperatively
Measured: From enrollment to 3. postoperative day
Secondary outcomes (10)
Cardiovascular injury
Change in baseline of hs-cTnT and NT-proBNP
- baseline characteristics are measured before surgery
- measurements are repeated 1h after surgery and up to 3 days postoperatively (once a day)
Measured: From enrollment to 3. postoperative day
Clinical serious complications
Mortality, Bone cement implantation syndrome, serious cardiovascular complications (heart attack, heart failure, stroke, arrhythmia, peripheral artery thrombosis)
- data is collected trough Estonian National Health database "Digilugu"
- blood pressure, saturation and patient's mental state are monitored during the operation to register any case of bone cement implantation syndrome
Measured: From enrollment to 1 year postoperatively
Carotid-femoral pulse velocity
Measured with Sphygmocor XCEL
- baseline characteristics are measured before surgery
- measuring is repeated 24 h after surgery
Measured: From enrollment to 1. postoperative day
Augmentation index
Measured with Sphygmocor XCEL
- baseline characteristics are measured before surgery
- measuring is repeated 24 h after surgery
Measured: From enrollment to 1. postoperative day
Brain injury
Change in baseline of S-100B and NSE
- baseline characteristics are measured before surgery
- measuring is repeated 1h after surgery and up to 3 days postoperatively
Change in baseline of Choice-reaction test results done pre-and postoperatively
- baseline test result is measured before surgery
- measuring is repeated 24h after surgery
Measured: From enrollment to 3. postoperative day
Kidney Injury
Change in baseline of creatinine and cystatin C
- baseline characteristics are measured before surgery
- measuring is repeated 1h after surgery and up to 3 days postoperatively
Measured: From enrollment to 3. postoperative day
Total antioxidative capacity (TAC)
Change in baseline of total antioxidant capacity (TAC)
- baseline characteristics are measured before surgery
- measuring is repeated 1h after surgery and up to 3 days postoperatively
Measured: From enrollment to 3. postoperative day
Oxidative stress level (total peroxide levels)
Change in baseline total peroxide levels (TPX)
- baseline characteristics are measured before surgery
- measuring is repeated 1h after surgery and up to 3 days postoperatively
Measured: From enrollment to 3. postoperative day
Inflammation level
Change in baseline of inflammation markers (HIF1α, IL6, IL-1β, TNF-α, IL-10)
- baseline characteristics are measured before surgery
- measuring is repeated 1h after surgery and on the first postoperative day
Measured: From enrollment to 3. postoperative day
Low molecular weight metabolites (uM)
Change in baseline of:
Acylcarnitines Phosphatidylcholines Lysophosphatidylcholines Sphingomyelins Ceramides Dihydroceramides Hexosylceramides Dihexosylceramides Trihexosylceramides Cholesteryl esters Diglycerides Triglycerides Amino acids Amino acid related Bile acids Biogenic amines Carboxylic acids Fatty acids Hormones Indoles and derivatives
Measured: From enrollment to 1. postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start20 Mar 2024
- Primary completionMar 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaspar Tootsi, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323018
- Sponsor's protocol ID
- 384T-26
- Acronym
- PRINCIPAL
- Status last verified
- Apr 2024
- First submitted
- 13 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40550717
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remote Ischaemic Preconditioning in Cemented Total Hip Arthroplasty: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06323018
- Acronym / sponsor ID
- PRINCIPAL / 384T-26
- Conditions
- Osteoarthritis, Hip, Cardiovascular Diseases, Bone Cement Implantation Syndrome, Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Other: SHAMSHAM 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. |
| Remote Ischemic preconditioning group | Active comparator | Procedure: Remote Ischemic PreconditioningRIPC 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. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- age >65 years
- undergoing total hip cemented hip arthroplasty
Key exclusion criteria (2 listed)
- previously diagnosed peripheral artery disease on both upper limb
- RIPC is contraindicated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Ischemic Preconditioning4 cycles of 5 min pressure (produces an ischemia episode in subject's upper limb) with AutoRIC device (Starfish Medical, Canada) | Procedure or surgery | Remote Ischemic preconditioning group |
| SHAM4 cycles of 5min light pressure (no ischemia produced) with AutoRIC device (Starfish Medical, Canada) to imitate the RIPC procedure | Other | Control group |
Primary outcome
Myocardial injury
Time frame: From enrollment to 3. postoperative day
Peak hs-cTnT value * baseline characteristics are measured before surgery * measuring is repeated 1h after surgery and up to 3 days postoperatively
10 secondary outcomes
Cardiovascular injury
Time frame: From enrollment to 3. postoperative day
Clinical serious complications
Time frame: From enrollment to 1 year postoperatively
Carotid-femoral pulse velocity
Time frame: From enrollment to 1. postoperative day
Augmentation index
Time frame: From enrollment to 1. postoperative day
Brain injury
Time frame: From enrollment to 3. postoperative day
Kidney Injury
Time frame: From enrollment to 3. postoperative day
Total antioxidative capacity (TAC)
Time frame: From enrollment to 3. postoperative day
Oxidative stress level (total peroxide levels)
Time frame: From enrollment to 3. postoperative day
Inflammation level
Time frame: From enrollment to 3. postoperative day
Low molecular weight metabolites (uM)
Time frame: From enrollment to 1. postoperative day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Derived from this study: PubMed 40550717Ernits 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kaarel Ernits, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Ischemic Preconditioning in people with Osteoarthritis, Hip and Cardiovascular Diseases, run by University of Tartu at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaspar Tootsi, PhD (+372 7318282, kaspar.tootsi@kliinikum.ee), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial injury (time frame: From enrollment to 3. postoperative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06323018, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.