Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-25 @ 3:58 PM
Study NCT ID:
NCT07193368
Status:
COMPLETED
Last Update Posted:
2025-09-25
First Post:
2025-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intra-Articular Polyacrylamide Hydrogel Injections Improve Pain and Function in Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C016680', 'term': 'polyacrylamide gels'}, {'id': 'D007270', 'term': 'Injections, Intra-Articular'}], 'ancestors': [{'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 387}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2025-09-12', 'studyFirstSubmitQcDate': '2025-09-18', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Knee Pain (VAS Score)', 'timeFrame': 'Baseline and 12 months after injection', 'description': 'Pain intensity will be measured using the Visual Analogue Scale (VAS; 0-10, with 0 = no pain and 10 = worst pain). Baseline values will be compared with values at 12 months after injection.'}, {'measure': 'Change in Physical Function (WOMAC Function Subscale)', 'timeFrame': 'Baseline and 12 months after injection', 'description': 'Physical function will be assessed using the WOMAC Function subscale (0-68; higher scores indicate worse function). Baseline values will be compared with values at 12 months after injection.'}, {'measure': 'Change in Total WOMAC Score', 'timeFrame': 'Baseline and 12 months after injection', 'description': 'Overall knee function and symptoms will be assessed using the WOMAC total score (0-100; higher scores indicate worse symptoms and function). Baseline values will be compared with values at 12 months after injection.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis', 'Osteoarthritis', 'Osteoarthritis of the Knee', 'Degenerative Joint Disease of the Knee']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the effects of intra-articular injections of polyacrylamide hydrogel (Arthrosamid®) in patients with knee osteoarthritis. A total of 387 patients (593 knees) were treated across three medical centers in Türkiye.\n\nThe purpose of the study is to determine whether this injection can reduce knee pain and improve physical function in everyday life. Pain is being measured using a Visual Analogue Scale (VAS), and function is being assessed with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 40 years and older diagnosed with knee osteoarthritis (KL grade 2-4) who were treated with a single intra-articular polyacrylamide hydrogel injection at three medical centers in Türkiye and followed retrospectively for 12 months.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 40 years\n* Radiographic diagnosis of knee osteoarthritis (Kellgren-Lawrence grade 2-4)\n* Received intra-articular 2.5% polyacrylamide hydrogel injection\n\nExclusion Criteria:\n\n* Prior knee surgery before PAAG injection\n* Malignancy, local infection, or septic arthritis\n* Inflammatory joint disease (e.g., rheumatoid arthritis)\n* Pregnancy\n* Avascular necrosis\n* Advanced varus or valgus knee deformity'}, 'identificationModule': {'nctId': 'NCT07193368', 'acronym': 'HYDRO-KNEE', 'briefTitle': 'Intra-Articular Polyacrylamide Hydrogel Injections Improve Pain and Function in Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Intra-Articular Polyacrylamide Hydrogel Injections Improve Pain and Function in Knee Osteoarthritis: A Multicenter Retrospective Study.', 'orgStudyIdInfo': {'id': 'Approval No: 2025-14/3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Knee Osteoarthritis Patients', 'description': 'Patients diagnosed with knee osteoarthritis (Kellgren-Lawrence grade 2-4) who received a single intra-articular injection of 2.5% polyacrylamide hydrogel (Arthrosamid®, Contura, Denmark). Followed retrospectively for 12 months to assess pain (VAS) and function (WOMAC).', 'interventionNames': ['Biological: Polyacrylamide hydrogel 2.5% intra-articular injection']}], 'interventions': [{'name': 'Polyacrylamide hydrogel 2.5% intra-articular injection', 'type': 'BIOLOGICAL', 'otherNames': ['Arthrosamid®', 'iPAAG injection'], 'description': 'A single intra-articular injection of 2.5% cross-linked polyacrylamide hydrogel (iPAAG), composed of 2.5% polyacrylamide and 97.5% non-pyrogenic water. The product (Arthrosamid®, Contura, Denmark) was administered under ultrasound guidance into the knee joint. Patients were followed retrospectively for 12 months to evaluate safety and effectiveness in reducing pain (VAS) and improving function (WOMAC).', 'armGroupLabels': ['Knee Osteoarthritis Patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University, Faculty of Medicine, Department of Sports Medicine', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Feza Korkusuz MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dr. Özgür Oktay Nar Private Clinic, Bursa, Türkiye', 'class': 'UNKNOWN'}, {'name': 'Contura International A/S, Copenhagen, Denmark', 'class': 'UNKNOWN'}, {'name': 'Bursa City Hospital, Bursa, Türkiye', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Feza Korkusuz, MD - Professor of Sports Medicine, Hacettepe University Faculty of Medicine', 'investigatorFullName': 'Feza Korkusuz MD', 'investigatorAffiliation': 'Hacettepe University'}}}}