Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-28 @ 1:15 PM
Study NCT ID:
NCT06631456
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2024-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Platelet-Rich Plasma and Ozone Therapy in 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-05', 'studyFirstSubmitDate': '2024-10-05', 'studyFirstSubmitQcDate': '2024-10-05', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain-Numerical Rating Scale', 'timeFrame': 'From enrollment to the end of treatment at 3rd month', 'description': 'Pain level will be evaluated with the Numerical Rating Scale. (minimum: 0, maximum: 10)'}], 'secondaryOutcomes': [{'measure': 'Pain, stiffness and physical function-WOMAC', 'timeFrame': 'From enrollment to the end of treatment at 3rd month', 'description': 'The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a widely used self-administered health status measure used in assessing pain, stiffness, and function in patients with OA of the hip or knee. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each sub-scale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three sub-scales gives a total WOMAC score.'}, {'measure': 'Quality of life-SF-12', 'timeFrame': 'From enrollment to the end of treatment at 3rd month', 'description': 'The 12-item short-form health survey (SF-12) quality of life scale was used to evaluate general quality of life. It was presented as a physical component score (PCS) and mental component score (MCS). Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['knee osteoarthritis', 'platelet rich plasma', 'ozone therapy'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Knee osteoarthritis can frequently occur with advancing age. In cases of pain that persists despite hot/cold applications, drug therapy and exercise, intra-articular injections are considered. In advanced-stage gonarthrosis, steroid injections may respond. However, in mild and moderate knee arthritis, regenerative methods come to the forefront because the joint cartilage is still partially/completely intact. PRP and ozone therapy are frequently applied intra-articular treatments. This study will compare the effects of both injection methods on clinical outcomes.', 'detailedDescription': 'Knee osteoarthritis is a common arthrosis that can be encountered frequently with increasing life expectancy. In mild-moderate stages, hot/cold applications, drug treatments and exercise applications are usually applied, while in those who do not respond, physical therapy or intra-articular injection treatments are applied. This retrospective study aims to examine the effects of intra-articular Platelet Rich Plasma (PRP) and ozone therapy on pain, functionality and quality of life in patients with Stage 2-3 gonarthrosis according to the Kelgren-Lawrence (KL) Classification.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Stage 2-3 gonarthrosis according to KL who apply to our hospital\\'s Physical Medicine and Rehabilitation out-patient clinic will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 30-70 years old, Stage 2-3 gonarthrosis according to KL\n* Voluntariness to participate in the study\n\nExclusion Criteria:\n\n* Cognitive dysfunction\n* General medical condition is not suitable for injections and evaluations\n* History of knee injections in the last 3 months\n* History of previous knee surgery\n* Bleeding disorders or those taking medications that may cause bleeding disorders after injections'}, 'identificationModule': {'nctId': 'NCT06631456', 'briefTitle': 'Effects of Platelet-Rich Plasma and Ozone Therapy in Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Sisli Hamidiye Etfal Training and Research Hospital'}, 'officialTitle': 'Effects of Platelet-Rich Plasma and Ozone Therapy on Pain and Quality of Life in Knee Osteoarthritis: A Retrospective Study', 'orgStudyIdInfo': {'id': '09/07/2024-4460'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PRP group', 'description': 'Patients who received intra-articular PRP due to gonarthrosis', 'interventionNames': ['Other: PRP injection']}, {'label': 'Ozone group', 'description': 'Patients who received intra-articular ozone therapy due to gonarthrosis', 'interventionNames': ['Other: Ozone therapy']}], 'interventions': [{'name': 'PRP injection', 'type': 'OTHER', 'description': 'A total of 3 doses of intra-articular PRP were applied to the symptomatic knees of the patients under ultrasound guidance, once a week.', 'armGroupLabels': ['PRP group']}, {'name': 'Ozone therapy', 'type': 'OTHER', 'description': 'A total of 3 doses of intra-articular ozone therapy were applied to the symptomatic knees of the patients under ultrasound guidance, once a week.', 'armGroupLabels': ['Ozone group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Şişli Hamidiye Etfal Training and Research Hospital, İstanbul', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Banu Kuran, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Şişli Hamidiye Etfal Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sisli Hamidiye Etfal Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Selda Çiftci', 'investigatorAffiliation': 'Sisli Hamidiye Etfal Training and Research Hospital'}}}}