Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2026-01-07 @ 4:20 AM
Study NCT ID:
NCT02542592
Status:
COMPLETED
Last Update Posted:
2017-01-18
First Post:
2015-09-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Methylprednisolone on Immune Signaling in Hip-arthroplasty Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D008776', 'term': 'Methylprednisolone Hemisuccinate'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-17', 'studyFirstSubmitDate': '2015-09-03', 'studyFirstSubmitQcDate': '2015-09-03', 'lastUpdatePostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in concentration of plasma-STAT3 (Signal transducer and activator of transcription) from baseline to 48 hours after surgery', 'timeFrame': '48 hours after surgery'}], 'secondaryOutcomes': [{'measure': 'Change in concentration of plasma-STAT3 from baseline to 14 days after surgery', 'timeFrame': '14 days after surgery'}, {'measure': "Change in concentration of plasma-CREB (Adenosine 3',5'-monophosphate response element-binding protein) from baseline to 14 days after surgery", 'timeFrame': '14 days after surgery'}, {'measure': 'Change in concentration of plasma-NF-kB (Nuclear factor kB) from baseline to 14 days after surgery', 'timeFrame': '14 days after surgery'}, {'measure': 'Change in Surgical Recovery Scale score from baseline to 28 days after surgery', 'timeFrame': '28 days after surgery'}, {'measure': 'Change in modified WOMAC (Western Ontario and McMaster Universities Arthritis Index) score from baseline to 28 days after surgery', 'timeFrame': '28 days after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Glucocorticoids', 'Immune Signaling', 'Recovery', 'Hip arthroplasty, total'], 'conditions': ['Osteoarthrosis']}, 'referencesModule': {'references': [{'pmid': '22654121', 'type': 'BACKGROUND', 'citation': 'Stoecklein VM, Osuka A, Lederer JA. Trauma equals danger--damage control by the immune system. J Leukoc Biol. 2012 Sep;92(3):539-51. doi: 10.1189/jlb.0212072. Epub 2012 May 31.'}, {'pmid': '12409671', 'type': 'BACKGROUND', 'citation': 'Wilmore DW. From Cuthbertson to fast-track surgery: 70 years of progress in reducing stress in surgical patients. Ann Surg. 2002 Nov;236(5):643-8. doi: 10.1097/00000658-200211000-00015.'}, {'pmid': '1393463', 'type': 'BACKGROUND', 'citation': 'Baigrie RJ, Lamont PM, Kwiatkowski D, Dallman MJ, Morris PJ. Systemic cytokine response after major surgery. Br J Surg. 1992 Aug;79(8):757-60. doi: 10.1002/bjs.1800790813.'}, {'pmid': '11030163', 'type': 'BACKGROUND', 'citation': 'Giannoudis PV, Smith RM, Perry SL, Windsor AJ, Dickson RA, Bellamy MC. Immediate IL-10 expression following major orthopaedic trauma: relationship to anti-inflammatory response and subsequent development of sepsis. Intensive Care Med. 2000 Aug;26(8):1076-81. doi: 10.1007/s001340051320.'}, {'pmid': '25253674', 'type': 'RESULT', 'citation': 'Gaudilliere B, Fragiadakis GK, Bruggner RV, Nicolau M, Finck R, Tingle M, Silva J, Ganio EA, Yeh CG, Maloney WJ, Huddleston JI, Goodman SB, Davis MM, Bendall SC, Fantl WJ, Angst MS, Nolan GP. Clinical recovery from surgery correlates with single-cell immune signatures. Sci Transl Med. 2014 Sep 24;6(255):255ra131. doi: 10.1126/scitranslmed.3009701.'}, {'pmid': '32719355', 'type': 'DERIVED', 'citation': 'Ganio EA, Stanley N, Lindberg-Larsen V, Einhaus J, Tsai AS, Verdonk F, Culos A, Ghaemi S, Rumer KK, Stelzer IA, Gaudilliere D, Tsai E, Fallahzadeh R, Choisy B, Kehlet H, Aghaeepour N, Angst MS, Gaudilliere B. Preferential inhibition of adaptive immune system dynamics by glucocorticoids in patients after acute surgical trauma. Nat Commun. 2020 Jul 27;11(1):3737. doi: 10.1038/s41467-020-17565-y.'}]}, 'descriptionModule': {'briefSummary': 'The study evaluates the pathophysiological effects of a single dose Methylprednisolone administered prior to total hip-arthroplasty (THA) surgery. The investigators examine the effect on immune signaling and recovery after surgery.\n\nHalf of participants will receive intravenous Solu-Medrol 125 mg, while the other half will receive placebo.\n\nThe investigators hypothesize that the group receiving Methylprednisolone will experience a positive modulation of the immune response and an enhanced recovery.', 'detailedDescription': 'The anti-inflammatory effects of glucocorticoids are well known. The beneficial effects on postoperative pain, postoperative nausea and vomiting are well-documented.\n\nHip-arthroplasty surgery and the inflammatory stress response in general affect the potential of recovery. The basic physiological mechanisms behind restoration of recovery after surgery are still unresolved. The many different immune cells involved in the complex signal response enables wound healing and recovery, and the individual immune signal pattern might be able to predict recovery. The effects of glucocorticoids on this immune signal pattern is unknown and calls for further investigation.\n\nThe study is to be considered as exploratory. This study is embedded in a primary study registrated as: NCT02445898\n\nFor further details please view the EudraCT registration:\n\nEudraCT nr.: 2015-000102-19'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Osteoarthrosis\n* Undergoing total unilateral hip-arthroplasty surgery\n* Speak and understand Danish\n* Have given informed content\n\nExclusion Criteria:\n\n* Revision or bilateral hip-arthroplasty surgery\n* General anaesthesia\n* Allergy or intolerance towards Methylprednisolone\n* Local or systemic infection\n* Permanent systemic treatment with steroids within 30 days peroperatively\n* Insulin-dependent diabetes\n* Atrial fibrillation\n* Neurological disease incl. Parkinsons\n* Daily use of hypnotics or sedatives\n* Alcohol abuse \\>35 units per week\n* Active treatment of ulcer within 3 months preoperatively\n* Cancer disease\n* Autoimmune disease incl. rheumatoid arthritis\n* Pregnant or breast feeding women\n* Menopause \\<1 year'}, 'identificationModule': {'nctId': 'NCT02542592', 'briefTitle': 'Effect of Methylprednisolone on Immune Signaling in Hip-arthroplasty Patients', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Effect of Preoperative Intravenous High Dose Methylprednisolone on Immune Signaling in Patients Scheduled for Total Hip-arthroplasty', 'orgStudyIdInfo': {'id': 'HK_VL_08_2015a'}, 'secondaryIdInfos': [{'id': '2015-000102-19', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Methylprednisolone', 'description': 'Preoperative single high dose of Solu-Medrol 125 mg iv.', 'interventionNames': ['Drug: Methylprednisolone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Preoperative single dose of isotonic Sodium Chloride', 'interventionNames': ['Drug: Isotonic Sodium Chloride']}], 'interventions': [{'name': 'Methylprednisolone', 'type': 'DRUG', 'otherNames': ['Solu-Medrol'], 'description': 'Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride (placebo)', 'armGroupLabels': ['Methylprednisolone']}, {'name': 'Isotonic Sodium Chloride', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen NV', 'country': 'Denmark', 'facility': 'Copenhagen University Hospital, Bispebjerg'}], 'overallOfficials': [{'name': 'Viktoria Lindberg-Larsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Section for Surgical Pathophysiology, Rigshospitalet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bispebjerg Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD student', 'investigatorFullName': 'Viktoria Oline Lindberg-Larsen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}