Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-02-20 @ 11:49 PM
Study NCT ID:
NCT02176304
Status:
COMPLETED
Last Update Posted:
2017-06-01
First Post:
2014-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Injection Site Matter? A Randomized Controlled Trial to Evaluate Efficacy of Knee Intraarticular Injections on Improval of Patient Reported Outcomes.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-30', 'studyFirstSubmitDate': '2014-06-25', 'studyFirstSubmitQcDate': '2014-06-26', 'lastUpdatePostDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short Term Pain improvement', 'timeFrame': '1 week'}, {'measure': 'Medium Term Pain Improvement', 'timeFrame': '1 month'}, {'measure': 'Self Reported Patient Scores Improvement', 'timeFrame': '1 month', 'description': 'WOMAC and Visual Analog Scale will be used to monitor improvement'}], 'secondaryOutcomes': [{'measure': 'Pain on injection site', 'timeFrame': 'baseline', 'description': 'Will compare pain on site of injection on study arms.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['knee', 'arthritis', 'injections', 'corticosteroids'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Knee osteoarthritis is one of the most prevalent orthopedic conditions worldwide. With the aging population, a 40% patient increase is expected to present at clinics with complaints of primary osteoarthritis by 2025. Multiple studies have attempted to establish non-surgical criteria for knee arthritis and usage of resources to avoid major surgery. It has long been accepted as a treatment option for patients who have failed to respond to NSAIDs and other non-surgical therapies to receive intra-articular injections of steroid and anesthesia mixtures to hold off disease progression.\n\nVarious studies have compared different sites of injection and the accuracy rate of the injection being within the joint. Recent studies report a 66% accuracy on palpation-guided injection on the anterolateral knee, 93% accuracy on palpation-guided injection on the superolateral portal of the knee, and new studies show an improvement of up to 98% with use of ultrasound guiding software. However, in a health care system with limited resources, providing patients with US-guided injections represented an increased cost of $178.35 per patient as per 2010 Medicare reports.\n\nTherefore, assuming these accuracy rates, we will compare the anterolateral and superolateral portals for knee injection and their clinical effect to monitor if in fact there is a difference in patient reported outcomes. As a secondary analysis, if no difference is found, a strong case for palpation-guided injections versus ultrasound-guided injections can be made.\n\nIn this study we will prospectively enroll 60 patients to be divided into two 30 patient groups with primary knee osteoarthritis. Patients that qualify as subjects will be treated with an intraarticular knee injection through an anterolateral portal or a suprapatellar portal as per group in which they are placed. Scores will be given for pain of the injection and of the baseline illness and compared on a subsequent visit to assess self-reported functional outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria include Early osteoarthritis as per Brandt grades, persistent joint pain warranting a clinic visit, no previous injections given, significant pain in visual analog scale, failure of exercise and oral analgesics.\n\nExclusion Criteria:\n\n* Exclusion criteria include advanced knee osteoarthritis, patients with bloody effusions, the use of warfarin or antiplatelet therapy, presence of any infection, patients with arthritis other than primary osteoarthritis, patients younger than age 25 due to low likelihood of primary arthritis, pregnant females, diabetics with poor glucose control, and patients that have previously been injected in knee(s).'}, 'identificationModule': {'nctId': 'NCT02176304', 'briefTitle': 'Does Injection Site Matter? A Randomized Controlled Trial to Evaluate Efficacy of Knee Intraarticular Injections on Improval of Patient Reported Outcomes.', 'organization': {'class': 'OTHER', 'fullName': 'University of Puerto Rico'}, 'officialTitle': 'Does Injection Site Matter? A Randomized Controlled Trial to Evaluate Efficacy of Knee Intraarticular Injections on Improval of Patient Reported Outcomes.', 'orgStudyIdInfo': {'id': 'Knee Injections'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Suprapatellar Knee Injection Site', 'description': 'Patients will be injected specified dose of lidocaine and depomedrol through suprapatellar-lateral knee entry site.', 'interventionNames': ['Drug: Depomedrol', 'Drug: Lidocaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Anterolateral knee injection', 'description': 'Patients will be injected specified dose of lidocaine and depomedrol through anterolateral knee entry site.', 'interventionNames': ['Drug: Depomedrol', 'Drug: Lidocaine']}], 'interventions': [{'name': 'Depomedrol', 'type': 'DRUG', 'otherNames': ['Depomedrol 40 mg/ml'], 'description': 'Depomedrol 40 mg/ml, 1 ml injected to knee on day one of intervention.', 'armGroupLabels': ['Anterolateral knee injection', 'Suprapatellar Knee Injection Site']}, {'name': 'Lidocaine', 'type': 'DRUG', 'otherNames': ['Lidocaine 2%'], 'description': 'Lidocaine 2% soln, 4 ml injected to knee on day 1 of intervention', 'armGroupLabels': ['Anterolateral knee injection', 'Suprapatellar Knee Injection Site']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00918', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'University of Puerto Rico School Of Medicine Outpatient Clinics', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Ariel D Davila-Parrilla, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Puerto Rico Orthopedics Department'}, {'name': 'Antonio Otero-Lopez, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Puerto Rico Orthopedics Department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Puerto Rico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Orthopedic Surgeon', 'investigatorFullName': 'Ariel D. Davila Parrilla, MD', 'investigatorAffiliation': 'University of Puerto Rico'}}}}