Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-01-03 @ 8:05 PM
Study NCT ID:
NCT02253966
Status:
COMPLETED
Last Update Posted:
2016-06-06
First Post:
2014-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Intraarticular Injection of Methylprednisolone in Patients Scheduled for Total Knee-arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006930', 'term': 'Hyperalgesia'}], 'ancestors': [{'id': 'D020886', 'term': 'Somatosensory Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077555', 'term': 'Methylprednisolone Acetate'}, {'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D008775', 'term': 'Methylprednisolone'}, {'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': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'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'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-03', 'studyFirstSubmitDate': '2014-09-29', 'studyFirstSubmitQcDate': '2014-09-30', 'lastUpdatePostDateStruct': {'date': '2016-06-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': '24 hours postoperatively', 'description': 'Pain intensity on a numeric rang scale (NRS) from 0 to 10 upon ambulation 24 hours following surgery'}], 'secondaryOutcomes': [{'measure': 'Pain', 'timeFrame': '48 hours postoperatively', 'description': 'Pain intensity on a NRS from 0 to 10 upon ambulation 48 hours following'}, {'measure': 'Pain', 'timeFrame': 'From day 1 to day 14', 'description': 'Diary-reported pain intensity on a NRS from 0 to 10 when walking. Once daily from first to fourteenth postoperative day'}, {'measure': 'Pain', 'timeFrame': 'From day 1 to day 14', 'description': 'Diary-reported pain intensity on a NRS from 0 to 10 upon rest. Once daily from first to fourteenth postoperative day'}, {'measure': 'Sensitisation', 'timeFrame': 'On day 0 and day 2', 'description': 'Quantitative sensory testing (temporal summation / pressure algometry) on the day of surgery and on the second postoperative day.'}, {'measure': 'Inflammation', 'timeFrame': 'On day 0 and day 2', 'description': 'Measurement of C-reactive protein in blood sample on the day of surgery and on the second postoperative day.'}, {'measure': 'Inflammation', 'timeFrame': 'On day 0', 'description': 'Measurement of interleukin-6 level in knee joint fluid on the day of surgery.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Knee Joint Osteoarthrosis', 'Hyperalgesia', 'Severe Movement Related Pain']}, 'descriptionModule': {'briefSummary': 'Despite improvements in analgesic treatment following total knee arthroplasty (TKA) for osteoarthrosis, a substantial part of patients still have severe acute pain after surgery. It has been suggested that preoperative degree of intraarticular inflammation is associated to postoperative degree of pain and level of function. Furthermore it is known, that patients with preoperative inflammation have hyperalgesia and severe movement related pain.\n\nThe aim of this study is to investigate the effect of a preoperative intraarticular injection of Methylprednisoloneacetate in reducing acute postoperative pain after total knee arthroplasty in patients with signs of severe pre-operative inflammation and pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 50 -80\n* Osteoarthrosis\n* Scheduled for primary unilateral TKA\n* Preoperative pain report with NRS \\> 5 upon walking\n* Signs of sensitisation in knee\n\nExclusion Criteria:\n\n* Allergies to methylprednisoloneacetate, lidocaine or standard analgesic treatment\n* Deficient written or spoken danish\n* Impairment from psychological or neurological disease\n* Local og systemic infection\n* Immunodeficiency\n* Treatment with corticosteroid within 30 days of inclusion\n* Insulin treated diabetes mellitus\n* Anticoagulant therapy\n* ASA (American Society of Anaesthesia) class \\> 3\n* General anaesthesia\n* Alchohol use \\> 21 units / week\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02253966', 'briefTitle': 'Preoperative Intraarticular Injection of Methylprednisolone in Patients Scheduled for Total Knee-arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'orgStudyIdInfo': {'id': 'H-3-2014-089'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Methylprednisoloneacetate', 'description': 'Administration of:\n\n1 ml methylprednisoloneacetate 40 mg/ml 5 ml lidocaine 20 mg/ml 4 ml sodium chloride 9 mg/ml as a single intraarticular injection 7 days prior to surgery.', 'interventionNames': ['Drug: Methylprednisoloneacetate', 'Drug: Lidocaine', 'Other: sodium chloride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sodium chloride', 'description': 'Administration of:\n\n5 ml lidocaine 20 mg/ml 5 ml sodium chloride 9 mg/ml as a singe intraarticular injection 7 days prior to surgery.', 'interventionNames': ['Drug: Lidocaine', 'Other: sodium chloride']}], 'interventions': [{'name': 'Methylprednisoloneacetate', 'type': 'DRUG', 'otherNames': ['Depo-Medrol'], 'armGroupLabels': ['Methylprednisoloneacetate']}, {'name': 'Lidocaine', 'type': 'DRUG', 'armGroupLabels': ['Methylprednisoloneacetate', 'Sodium chloride']}, {'name': 'sodium chloride', 'type': 'OTHER', 'otherNames': ['saline'], 'armGroupLabels': ['Methylprednisoloneacetate', 'Sodium chloride']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Hellerup', 'country': 'Denmark', 'facility': 'Gentofte Hospital', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lundbeck Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Research Fellow', 'investigatorFullName': 'Iben Engelund Luna', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}