Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT06141018
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-21
First Post:
2023-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness and Safety of Intra-articular SEMICAL GEL-B CROSS Therapy in Knee Osteoarthritis (SEM-ART1)
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Triple-blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 102}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-15', 'studyFirstSubmitDate': '2023-10-25', 'studyFirstSubmitQcDate': '2023-11-17', 'lastUpdatePostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain scores', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, and 12 months.', 'description': 'The alteration in pain arising from knee osteoarthritis will be assessed in correlation with changes in WOMAC pain scores at baseline, 3 months, 6 months, 9 months, and 12 months.'}], 'secondaryOutcomes': [{'measure': 'Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) function score', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, and 12 months.', 'description': 'The alteration in pain arising from knee osteoarthritis will be assessed in correlation with changes in WOMAC pain scores at baseline, 3 months, 6 months, 9 months, and 12 months.'}, {'measure': 'Changes in knee functions', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, and 12 months.', 'description': 'The alteration in function arising from knee osteoarthritis will be assessed in correlation with changes in WOMAC pain scores at baseline, 3 months, 6 months, 9 months, and 12 months.'}, {'measure': 'Changes in knee flexor muscle strength', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, and 12 months.', 'description': 'Knee flexor muscle strength assessed by myometer'}, {'measure': 'Changes in knee extensor muscle strength', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, and 12 months.', 'description': 'Knee extensor muscle strength assessed by myometer'}, {'measure': 'Changes in knee functions during 5 times sit to stand test', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, and 12 months.', 'description': '5 times sit to stand test'}, {'measure': 'Changes in knee functions by 6MWT (6 Minute Walking Test)', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, and 12 months.', 'description': '6 minute walking test'}, {'measure': 'Change in the need for analgesic drug from pre-treatment to post-treatment', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, and 12 months.', 'description': 'Will be assessed by patient diary'}, {'measure': 'Change in quality of life', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, and 12 months.', 'description': 'Will be assessed by 36-item Short Form Survey'}, {'measure': 'Change in knee pain during movement and rest', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, and 12 months.', 'description': 'Will be assessed by Visual Analogue Scale 1-10 (1: no pain, 10: very much pain)'}, {'measure': 'Local reactions in the injection site', 'timeFrame': '7-10 days post-injection', 'description': 'A safety visit will be performed 7-10 days after administration of the treatment injection and the injection site will be visually assessed for local reactions.'}, {'measure': 'Adverse events throughout the entire study period', 'timeFrame': 'Through study completion, an average of 1 year.', 'description': 'Adverse events will be questioned throughout the entire study period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['knee osteoarthritis', 'hyaluronic acid', 'intraarticular injection', 'viscosupplementation'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the effectiveness and safety of intra-articular injection of a cross-linked sodium hyaluronate; SEMICAL GEL-B CROSS, in knee osteoarthritis.\n\nPrimary objectives: The aim of this study is to obtain short- and long-term clinical data on the performance and safety of intra-articular injection of SEMICAL GEL B-CROSS, produced and marketed by Semical Biosurgery incorporated company, in knee osteoarthritis patients.\n\nIt is also aimed to monitoring known adverse events and complications, detecting previously unknown adverse events and complications, to identify and analyze emerging risks based on real-life data. Participants will receive intra-articular injection of either a cross-linked sodium hyaluronate (SEMICAL GEL-B CROSS); or placebo (isotonic saline solution) at baseline, and will be followed-up for one year to compare the effectiveness and safety of the given therapy.', 'detailedDescription': 'The study is a randomized controlled, double-blind, two-armed, single-center and cross-over study. After a maximum screening period of 28 days, patients with Kellgren \\& Lawrence Stage II and III knee osteoarthritis will be randomly assigned to one of the two treatment arms on the day of injection, which is considered Day 0. These treatment arms are:\n\nGroup 1: Treatment Arm - Cross-linked intra-articular hyaluronic acid (90 mg 3 ml cross-linked hyaluronic acid)\n\nGroup 2: Control Arm - Intra-articular isotonic saline solution (3 ml 0.9% isotonic saline) A safety visit will be made 7-10 days after administration of the treatment injection and the injection site will be visually evaluated for local reactions. In addition, an inquiry for injection-related adverse events will also be conducted.\n\nTreatment responses of patients in both groups will be evaluated by a separate researcher blinded to study treatment with predefined objective response criteria.\n\nAt the 3rd month visit, the patients in both groups will be crossed-over and those who received a placebo at baseline will receive a hyaluronic acid injection at the 3rd month, while those who receive a hyaluronic acid injection at baseline will receive a placebo at the 3rd month. Efficacy evaluations will continue to be made at every three months for one year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 and over, both male and female\n* Diagnosed with clinical knee osteoarthritis according to the American College of\n* Rheumatology (ACR) criteria, with Kellgren \\& Lawrence stage II and III osteoarthritic findings on antero-posterior knee radiographs\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06141018', 'briefTitle': 'Effectiveness and Safety of Intra-articular SEMICAL GEL-B CROSS Therapy in Knee Osteoarthritis (SEM-ART1)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Semikal Technology'}, 'officialTitle': 'Safety and Effectiveness of Intra-articular Injection of a Cross-linked Sodium Hyaluronate in Knee Osteoarthritis: A Randomized, Prospective, Double-blind, Placebo-controlled, Cross-over, Post-marketing Clinical Follow-up Study', 'orgStudyIdInfo': {'id': 'SEM-ART1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cross-linked intra-articular hyaluronic acid', 'description': 'Cross-linked intra-articular hyaluronic acid (90 mg 3 ml cross-linked hyaluronic acid)', 'interventionNames': ['Device: Cross-linked intra-articular hyaluronic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Intra-articular isotonic saline solution (3 ml 0.9% isotonic saline) at the same dose as the treatment arm', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Cross-linked intra-articular hyaluronic acid', 'type': 'DEVICE', 'description': 'Patients in the treatment arm will receive 3 ml, 90 mg hyaluronic acid injection intra-articularly, while the ones in the placebo arm will receive 3 ml saline injection intra-articularly. The groups will be crossed-over at 3rd month.', 'armGroupLabels': ['Cross-linked intra-articular hyaluronic acid']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['3 ml isotonic saline solution'], 'description': 'Patients in the treatment arm will receive 3 ml, 90 mg hyaluronic acid injection intra-articularly, while the ones in the placebo arm will receive 3 ml saline injection intra-articularly. The groups will be crossed-over at 3rd month.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'Antalya Training and Research Hospital', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}], 'overallOfficials': [{'name': 'Aslıhan Kara', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Semikal Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Study protocol will be published as an article.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Semikal Technology', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Antalya Training and Research Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}