Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2026-02-27 @ 10:01 AM
Study NCT ID:
NCT04111718
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-30
First Post:
2019-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Procedural Awareness of Knee Injections for Osteoarthritis on Patient Perceptions of Effectiveness
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 158}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-27', 'studyFirstSubmitDate': '2019-09-30', 'studyFirstSubmitQcDate': '2019-09-30', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS Pain', 'timeFrame': '12 weeks', 'description': 'Visual analog scale pain on a 0-10 scale, with higher scores indicating worse pain.'}], 'secondaryOutcomes': [{'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)', 'timeFrame': '12 weeks', 'description': 'Patient reported knee osteoarthritis index with subscores of pain, function and stiffness. The range of scores on the WOMAC is from 0-96, with higher scores indicating worse outcomes. The subscore of pain is on a scale of 0-20, the subscore of stiffness is 0-8, and the subscale of function is 0-68. The scores of the subscales are summed in order to get the total score.'}, {'measure': 'Range of motion', 'timeFrame': '12 weeks', 'description': 'Range of motion in the knee from full extension to full flexion.'}, {'measure': 'Short Form 12 (SF-12) Functional outcome assessment', 'timeFrame': '12 weeks', 'description': 'Health-related quality of life measure on a scale from 0-100, where higher scores indicate better function.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether outcomes for patients receiving intra-articular platelet-rich plasma (PRP) injections for knee osteoarthritis are influenced by observation of the preparatory steps to the procedure. The viewing of the steps involved in the administration of PRP may increase the effectiveness of the treatment in comparison to patients who have not observed the preparatory steps.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult men or women ages 50-80 years\n* Diagnosis of symptomatic osteoarthritis of the knee based on clinical and radiographic criteria\n* Provision of informed consent\n\nExclusion Criteria:\n\n* Patients with inflammatory osteoarthritis\n* Open wounds or sores over the knee joint\n* Patients that will likely have problems, in the judgement of the investigators, with maintaining follow-up'}, 'identificationModule': {'nctId': 'NCT04111718', 'briefTitle': 'The Impact of Procedural Awareness of Knee Injections for Osteoarthritis on Patient Perceptions of Effectiveness', 'organization': {'class': 'INDUSTRY', 'fullName': 'ArthroBiologix Inc.'}, 'officialTitle': 'The Impact of Procedural Awareness of Knee Injections for Osteoarthritis on Patient Perceptions of Effectiveness', 'orgStudyIdInfo': {'id': 'ABx-prp-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Viewing of preparation', 'description': 'The patient will be in the room for the preparation of the PRP and will receive a description of the centrifuge process from the physician administering the injection.', 'interventionNames': ['Biological: Platelet-rich plasma (PRP)', 'Behavioral: Viewing of preparation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Blinded to preparation', 'description': 'The patient will leave the room after their blood is drawn and will not view the preparation of the PRP, and will also not receive a description of the centrifuge process.', 'interventionNames': ['Biological: Platelet-rich plasma (PRP)']}], 'interventions': [{'name': 'Platelet-rich plasma (PRP)', 'type': 'BIOLOGICAL', 'description': 'Autologous platelet-rich plasma which will be derived from blood drawn from the patient.', 'armGroupLabels': ['Blinded to preparation', 'Viewing of preparation']}, {'name': 'Viewing of preparation', 'type': 'BEHAVIORAL', 'description': 'The patient will receive a description of the preparation process and will view the preparation in the centrifuge.', 'armGroupLabels': ['Viewing of preparation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'ArthroBiologix', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Moin Khan, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ArthroBiologix Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}