Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT00968903
Status:
COMPLETED
Last Update Posted:
2011-09-29
First Post:
2009-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Methylprednisolone After Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D014839', 'term': 'Vomiting'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008775', 'term': 'Methylprednisolone'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-28', 'studyFirstSubmitDate': '2009-08-28', 'studyFirstSubmitQcDate': '2009-08-28', 'lastUpdatePostDateStruct': {'date': '2011-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to fulfill discharge criteria', 'timeFrame': 'At discharge (mean 1-2 days)'}], 'secondaryOutcomes': [{'measure': 'Hand muscle strength', 'timeFrame': '24 hours'}, {'measure': 'Sleeping quality on the visual analog scale', 'timeFrame': 'up to four days'}, {'measure': 'Inflammatory response measured as CRP in blood sample', 'timeFrame': '24 hours postoperatively'}, {'measure': 'Fatigue measured on a 10 point numeric range scale', 'timeFrame': 'up to four days'}, {'measure': 'Additional analgetics, antinausea agents and sleeping medicine.', 'timeFrame': 'up to four days', 'description': 'Measures as mg (analgetics) and daily use (yes or no)(antinausea agents and sleeping medicine).'}, {'measure': 'Number of Participants with Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': 'up to 30 days'}, {'measure': 'Postoperative pain scores on the visual analog scale', 'timeFrame': 'up 30 days'}, {'measure': 'Postoperative nausea and vomiting (PONV) on 4 point numeric range scale', 'timeFrame': 'up to 4 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hip arthroplasty', 'Methylprednisolone', 'Post-operative pain'], 'conditions': ['LOS', 'Postoperative Pain', 'Postoperative Nausea and Vomiting', 'Sleeping Quality', 'Fatigue', 'Inflammatory Response']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare the effects of pre-operative methylprednisolone (125mg iv) versus placebo on postoperative outcome after hip arthroplasty.\n\nThe hypothesis is that pre-operative methylprednisolone (125mg iv) will reduce time to fulfill discharge criteria.', 'detailedDescription': "In spite of being one of the last century's most successful surgical procedures in treatment of advanced osteoarthritis total hip arthroplasty is still associated with postoperative pain and delayed rehabilitation. The investigators therefore decided to evaluate the effects of pre-operative methylprednisolone (125mg iv) versus placebo on postoperative outcome in a well defined fast-track setup after hip arthroplasty."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective total hip arthroplasty\n* Able to speak and understand danish\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Alcohol or medical abuse\n* Allergies to local anesthetics or methylprednisolone\n* Age \\< 18 years\n* Daily use of opioids or glucocorticoids\n* Pregnancy or breastfeeding (fertile women)'}, 'identificationModule': {'nctId': 'NCT00968903', 'briefTitle': 'Effects of Methylprednisolone After Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'Effects of Pre-operative Methylprednisolone (125mg iv) After Total Hip Arthroplasty: A Prospective, Randomized, Double-blind, Placebo-controlled Trail', 'orgStudyIdInfo': {'id': 'H-A-2008-030'}, 'secondaryIdInfos': [{'id': '2009-41-3784'}, {'id': '2612-3916'}, {'id': 'EudraCT: 2008-006528-67'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Methylprednisolone', 'description': 'Methylprednisolone 125 mg iv pre-operatively', 'interventionNames': ['Drug: Methylprednisolone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'description': 'Saline iv pre-operatively in equivalent volume (placebo)', 'interventionNames': ['Drug: Methylprednisolone']}], 'interventions': [{'name': 'Methylprednisolone', 'type': 'DRUG', 'description': 'Methylprednisolone 125 mg iv pre-operatively', 'armGroupLabels': ['Methylprednisolone', 'Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Copenhagen', 'state': 'Hvidovre', 'country': 'Denmark', 'facility': 'Hvidovre University Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lundbeck Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Troels Haxholdt Lunn', 'investigatorAffiliation': 'Hvidovre University Hospital'}}}}