Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT06323018
Status:
RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Remote Ischaemic Preconditioning in Cemented Hip Arthroplasty.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C005703', 'term': 'salicylhydroxamic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-03', 'studyFirstSubmitDate': '2024-03-13', 'studyFirstSubmitQcDate': '2024-03-19', 'lastUpdatePostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myocardial injury', 'timeFrame': 'From enrollment to 3. postoperative day', 'description': 'Peak hs-cTnT value\n\n* baseline characteristics are measured before surgery\n* measuring is repeated 1h after surgery and up to 3 days postoperatively'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular injury', 'timeFrame': 'From enrollment to 3. postoperative day', 'description': 'Change in baseline of hs-cTnT and NT-proBNP\n\n* baseline characteristics are measured before surgery\n* measurements are repeated 1h after surgery and up to 3 days postoperatively (once a day)'}, {'measure': 'Clinical serious complications', 'timeFrame': 'From enrollment to 1 year postoperatively', 'description': 'Mortality, Bone cement implantation syndrome, serious cardiovascular complications (heart attack, heart failure, stroke, arrhythmia, peripheral artery thrombosis)\n\n* data is collected trough Estonian National Health database "Digilugu"\n* blood pressure, saturation and patient\'s mental state are monitored during the operation to register any case of bone cement implantation syndrome'}, {'measure': 'Carotid-femoral pulse velocity', 'timeFrame': 'From enrollment to 1. postoperative day', 'description': 'Measured with Sphygmocor XCEL\n\n* baseline characteristics are measured before surgery\n* measuring is repeated 24 h after surgery'}, {'measure': 'Augmentation index', 'timeFrame': 'From enrollment to 1. postoperative day', 'description': 'Measured with Sphygmocor XCEL\n\n* baseline characteristics are measured before surgery\n* measuring is repeated 24 h after surgery'}, {'measure': 'Brain injury', 'timeFrame': 'From enrollment to 3. postoperative day', 'description': 'Change in baseline of S-100B and NSE\n\n* baseline characteristics are measured before surgery\n* measuring is repeated 1h after surgery and up to 3 days postoperatively\n\nChange in baseline of Choice-reaction test results done pre-and postoperatively\n\n* baseline test result is measured before surgery\n* measuring is repeated 24h after surgery'}, {'measure': 'Kidney Injury', 'timeFrame': 'From enrollment to 3. postoperative day', 'description': 'Change in baseline of creatinine and cystatin C\n\n* baseline characteristics are measured before surgery\n* measuring is repeated 1h after surgery and up to 3 days postoperatively'}, {'measure': 'Total antioxidative capacity (TAC)', 'timeFrame': 'From enrollment to 3. postoperative day', 'description': 'Change in baseline of total antioxidant capacity (TAC)\n\n* baseline characteristics are measured before surgery\n* measuring is repeated 1h after surgery and up to 3 days postoperatively'}, {'measure': 'Oxidative stress level (total peroxide levels)', 'timeFrame': 'From enrollment to 3. postoperative day', 'description': 'Change in baseline total peroxide levels (TPX)\n\n* baseline characteristics are measured before surgery\n* measuring is repeated 1h after surgery and up to 3 days postoperatively'}, {'measure': 'Inflammation level', 'timeFrame': 'From enrollment to 3. postoperative day', 'description': 'Change in baseline of inflammation markers (HIF1α, IL6, IL-1β, TNF-α, IL-10)\n\n* baseline characteristics are measured before surgery\n* measuring is repeated 1h after surgery and on the first postoperative day'}, {'measure': 'Low molecular weight metabolites (uM)', 'timeFrame': 'From enrollment to 1. postoperative day', 'description': 'Change in baseline of:\n\nAcylcarnitines 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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis, Hip', 'Cardiovascular Diseases', 'Bone Cement Implantation Syndrome', 'Kidney Diseases']}, 'referencesModule': {'references': [{'pmid': '40550717', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>65 years\n* undergoing total hip cemented hip arthroplasty\n\nExclusion Criteria:\n\n* previously diagnosed peripheral artery disease on both upper limb\n* RIPC is contraindicated'}, 'identificationModule': {'nctId': 'NCT06323018', 'acronym': 'PRINCIPAL', 'briefTitle': 'Effects of Remote Ischaemic Preconditioning in Cemented Hip Arthroplasty.', 'organization': {'class': 'OTHER', 'fullName': 'University of Tartu'}, 'officialTitle': 'Effects of Remote Ischaemic Preconditioning in Cemented Total Hip Arthroplasty: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '384T-26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control 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.', 'interventionNames': ['Other: SHAM']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Remote Ischemic preconditioning 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.', 'interventionNames': ['Procedure: Remote Ischemic Preconditioning']}], 'interventions': [{'name': 'Remote Ischemic Preconditioning', 'type': 'PROCEDURE', 'description': "4 cycles of 5 min pressure (produces an ischemia episode in subject's upper limb) with AutoRIC device (Starfish Medical, Canada)", 'armGroupLabels': ['Remote Ischemic preconditioning group']}, {'name': 'SHAM', 'type': 'OTHER', 'description': '4 cycles of 5min light pressure (no ischemia produced) with AutoRIC device (Starfish Medical, Canada) to imitate the RIPC procedure', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50406', 'city': 'Tartu', 'state': 'Tartu', 'status': 'RECRUITING', 'country': 'Estonia', 'contacts': [{'name': 'Kaspar Tootsi, MD, PhD', 'role': 'CONTACT', 'email': 'kaspar.tootsi@kliinikum.ee', 'phone': '+3727318282'}], 'facility': 'University of Tartu', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}], 'centralContacts': [{'name': 'Kaspar Tootsi, PhD', 'role': 'CONTACT', 'email': 'kaspar.tootsi@kliinikum.ee', 'phone': '+372 7318282'}, {'name': 'Kaarel Ernits, MD', 'role': 'CONTACT', 'email': 'kaarel.ernits@kliinikum.ee'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Tartu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kaspar Tootsi', 'investigatorAffiliation': 'University of Tartu'}}}}