Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-25 @ 2:08 PM
Study NCT ID:
NCT01303666
Status:
COMPLETED
Last Update Posted:
2017-04-24
First Post:
2011-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tidal Irrigation Versus Intra-articular Steroid Injection in the Treatment of Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061888', 'term': 'Craniospinal Irradiation'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-21', 'studyFirstSubmitDate': '2011-01-27', 'studyFirstSubmitQcDate': '2011-02-24', 'lastUpdatePostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WOMAC pain (WP)score', 'timeFrame': 'Weeks 0'}, {'measure': 'Visual Analogue Scale', 'timeFrame': 'Weeks 0'}, {'measure': 'WOMAC pain (WP)score', 'timeFrame': 'Weeks 2'}, {'measure': 'WOMAC pain (WP)score', 'timeFrame': 'Weeks 4'}, {'measure': 'WOMAC pain (WP)score', 'timeFrame': 'Weeks 12'}, {'measure': 'WOMAC pain (WP)score', 'timeFrame': 'Weeks 26'}, {'measure': 'Visual Analogue Scale', 'timeFrame': 'Weeks 2'}, {'measure': 'Visual Analogue Scale', 'timeFrame': 'Weeks 4'}, {'measure': 'Visual Analogue Scale', 'timeFrame': 'Weeks 12'}, {'measure': 'Visual Analogue Scale', 'timeFrame': 'Weeks 26'}], 'secondaryOutcomes': [{'measure': 'WOMAC physical function score (WF)', 'timeFrame': 'Weeks 0,2,4,12,26'}, {'measure': 'Overall assessment of the impact of the procedure by the patient (five point scale) (PA)', 'timeFrame': 'Weeks 0,2,4,12,26'}, {'measure': 'Overall assessment of the impact of the procedure by the blinded clinician (five point scale)(CA)', 'timeFrame': 'Weeks 0,2,4,12,26'}, {'measure': 'Time to walk fifty metre', 'timeFrame': 'Weeks 0,2,4,12,26'}, {'measure': 'Analgesic intake', 'timeFrame': 'Weeks 0,2,4,12,26'}, {'measure': 'Side effects of the procedure', 'timeFrame': 'Weeks 0,2,4,12,26'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Previous studies have indicated that patient expectations, beliefs and preferences may have an impact on treatment outcomes. The KIVIS study was primarily designed to compare two effective treatments for knee osteoarthritis (tidal irrigation (medical washout of the knee) or intra-articular corticosteroid injection). At study entry any preference expressed by the patient for each of the treatment interventions was recorded. This study assessed the effects of two treatments given at a single time-point and hence the effects of patient preference could be assessed independently of any compliance issues.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of knee OA\n* Knee pain for most days of the prior month\n* Radiographic evidence consistent with knee OA\n* Aged between 40 and 90 years old\n\nExclusion Criteria:\n\n* Symptomatic hip OA\n* Co-existent inflammatory or crystal arthritis\n* Prior knee surgery\n* Injury to the knee in the preceding 6 months\n* Any intra-articular injection in the preceding 3 months\n* Inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT01303666', 'briefTitle': 'Tidal Irrigation Versus Intra-articular Steroid Injection in the Treatment of Knee Osteoarthritis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Portsmouth Hospitals NHS Trust'}, 'officialTitle': 'Tidal Irrigation Versus Intra-articular Steroid Injection in the Treatment of Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'SEO118'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TI of the knee', 'interventionNames': ['Procedure: TI of the knee']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intra-articular CSI', 'interventionNames': ['Procedure: Intra-articular CSI']}], 'interventions': [{'name': 'Intra-articular CSI', 'type': 'PROCEDURE', 'description': 'After full aseptic preparation, 40 mg triamcinolone acetonide and 2 ml 1% lignocaine were injected into the joint cavity using the medial patello-femoral approach via a 21-gauge needle.', 'armGroupLabels': ['Intra-articular CSI']}, {'name': 'TI of the knee', 'type': 'PROCEDURE', 'description': 'This was done as a day case procedure under local anaesthetic. The medial patello-femoral approach was used. After full aseptic preparation, the skin and soft tissues were infiltrated with 5e10 ml of 1% lignocaine. The joint was then instilled with a further 10 ml of 1% lignocaine.\n\nAfter an initial puncture using a scalpel, a 3.2 mm diameter wrist arthroscope was advanced into the joint cavity. Up to 1 l of 0.9% normal saline was then irrigated through the joint: saline was run into the joint until fully distended and then allowed to flow out of the joint in a cyclical method until the aspirated fluid runs clear for at least three successive cycles.', 'armGroupLabels': ['TI of the knee']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nigel K Arden', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MRC Epidemiology Resource Centre, Southampton General Hospital, Southampton, UK'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Portsmouth Hospitals NHS Trust', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Dr Jo Ledingham', 'oldOrganization': 'Portsmouth Hospitals NHS Trust'}}}}