Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-30 @ 11:48 PM
Study NCT ID:
NCT06946056
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-25
First Post:
2025-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect of Biofiller PRP Application on 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2025-04-09', 'studyFirstSubmitQcDate': '2025-04-18', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS) Change from baseline in pain on the VAS at month 3', 'timeFrame': 'Baseline and month 3', 'description': 'Visual Analog Scale (VAS) is used to measure and monitor the intensity of pain. This is a 10 cm ruler that describes painlessness at one end and the most severe pain at the other. A patient scores his/her pain from 0 to 10.'}], 'secondaryOutcomes': [{'measure': 'Western OntarioMacMaster (WOMAC) Change from baseline in pain and physical functions on Western OntarioMacMaster scale at month', 'timeFrame': 'Baseline and month 3', 'description': 'It is widely used in studies with knee OA patients. The scale, each question of which is evaluated with a 5-point Likert scale, consists of 24 questions. It is filled by patients. There are pain, physical function and stiffness subscales. Pain subscale is evaluated with five items and is scored between 0-20. The hardness subscale has two items and is scored between 0-8. Function subscale consists of 17 items and is scored between 0-68. A high score indicates poor function, pain or stiffness.'}, {'measure': 'Femoral cartilage thickness Change from baseline in knee joint on the measuring the femoral cartilage thickness at month 3', 'timeFrame': 'Baseline and month 3', 'description': 'Femoral cartilage thickness is measured by the same physician by placing the probe axially in the suprapatellar region by ultrasonography while the patient is lying on his back and the knees are in maximum flexion. The distance between the thin hyperechoic line at the synovial cartilage interface and the sharp hyperechoic line at the cartilage-bone interface is defined as cartilage thickness'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis', 'Biofiller PRP', 'Femoral Cartilage Thickness']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effects of biofiller PRP, on pain, range of motion, quality of life, and femoral cartilage thickness in patients with knee osteoarthritis.', 'detailedDescription': 'Patients who are admitted and diagnosed with knee osteoarthritis based on anamnesis, physical examination and imaging methods are included in the study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1-45-65 years old 2-Diagnosis of knee OA according to ACR clinical and radiological diagnostic criteria 3-Kellgren Lawrence stage II or III 4-Knee pain for at least 6 months 5-Visual analog scale (VAS) score of at least 3 or more\n\nExclusion Criteria:\n\n1 - History of surgery or traumatic injury 2-Inflammatory arthritis 3-History of cancer, bleeding diathesis and psychiatric disease 4-Those who have a disease that limits their participation in exercises (severe chronic obstructive lung disease, severe heart failure, history of cerebrovascular events) 5-Hip and ankle problems 6-Participating in another physical therapy program in the last 3 months 7-History of intra-articular injections in the last 6 months'}, 'identificationModule': {'nctId': 'NCT06946056', 'briefTitle': 'Evaluation of the Effect of Biofiller PRP Application on Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Necmettin Erbakan University'}, 'officialTitle': 'Evaluation of the Effect of Biofiller PRP Application on Range of Motion, Pain, Quality of Life and Femoral Cartilage Thickness in Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'Büşra Demirtaş'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Biofiller platelet rich plasma', 'description': "Ten ml of the patient's blood wasdrawn in a syringe pre-filled with 1 mLacid citrate dextrose(anticoagulant). It wascentrifuged firstat 4000 rotations per minute (RPM)for 15 min and thenat 1500 RPM for 5 min. The upper part,i.e.,platelet-poor plasma (PPP) was withdrawn in a 5 mL syringe. PRP was incubated in hot incubator at 100a °C for 5 min and then cooled in a refrigerator for 5 min.", 'interventionNames': ['Other: biofiller prp']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Platelet rich plasma', 'description': "Ten ml of the patient's blood wasdrawn in a syringe pre-filled with 1 mLacid citrate dextrose(anticoagulant). It wascentrifuged firstat 4000 rotations per minute (RPM)for 15 min and thenat 1500 RPM for 5 min. The upper part,i.e.,platelet-poor plasma (PPP) was withdrawn in a 5 mL syringe", 'interventionNames': ['Other: biofiller prp']}], 'interventions': [{'name': 'biofiller prp', 'type': 'OTHER', 'description': "Ten ml of the patient's blood was drawn in a syringe pre-filled with 1 mLacid citrate dextrose(anticoagulant). It wascentrifuged firstat 3500 rotations per minute (RPM)for 15 min and thenat 1500 RPM for 5 min. The upper part,i.e.,platelet-poor plasma (PPP) waswithdrawn in a 5 mL syringe. PPP wasincubated in hot water at 100a °C for 5 min and then cooled in a refrigerator for 5 min.The PRP injection was performed in a standardized manner and injected into the IA surface of the affected knee joint", 'armGroupLabels': ['Biofiller platelet rich plasma', 'Platelet rich plasma']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Konya', 'country': 'Turkey (Türkiye)', 'facility': 'NEU', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}], 'overallOfficials': [{'name': 'BANU ORDAHAN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Necmettin Erbakan University, Konya, Turkey'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Necmettin Erbakan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Banu Ordahan', 'investigatorAffiliation': 'Necmettin Erbakan University'}}}}