Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-05 @ 6:20 PM
Study NCT ID:
NCT04427657
Status:
COMPLETED
Last Update Posted:
2021-07-06
First Post:
2020-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Lipogems for 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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-02', 'studyFirstSubmitDate': '2020-04-22', 'studyFirstSubmitQcDate': '2020-06-09', 'lastUpdatePostDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptomatic and functional evaluation at 6 months by comparison of the KOOS score recorded between the two groups', 'timeFrame': '6 month', 'description': 'Symptomatic and functional evaluation at 6 months by comparison of the KOOS score recorded between two groups (6±1 months) undergoing arthroscopic debridement ± injection of autologous microfragmented lipoaspirate tissue (Lipogems®).'}], 'secondaryOutcomes': [{'measure': 'Radiological changes at 6 month recorded between the two groups', 'timeFrame': '6 month', 'description': 'Evaluation of possible radiological changes pre-operative and after 6±1 months by means of MagneticResonanceImaging analysis.'}, {'measure': 'Functional changes at 6 month recorded between the two groups', 'timeFrame': '6 month', 'description': 'Symptomatic and functional evaluation at 6±1 months by means of Proms that inclued questionnaire about quality of life (SF-12, WOMAC)'}, {'measure': 'Serum changes at 6 month recorded between the two groups', 'timeFrame': '6 month', 'description': 'Changes in serum levels of biomarkers related to Osteoarthritis (collagen type II C-telopeptide(CTx-II),collagen type III N-propeptide( PIIINP)) will be evaluated (pre-intervention vs 6±1 months).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Lipogems system consist in the use of a monouse kit for liposuction, processing and administration of adipose tissue. The use of the final product (microfragmented adipose tissue,not expanded) shoud promote the natural joint homeostasis, associated with a clinical improvement', 'detailedDescription': 'The Objectiveof the study is to analyse the therapeutic role of microfragmented autologous tissue for the treatment of the knee osteoarthritis (OA).\n\nMain purpose: Symptomatic and functional evaluation at 6 months by comparison of the Knee Injury and Osteoarthritis Outcome Score(KOOS) recorded between two groups (6±1 months) undergoing arthroscopic debridement ± injection of autologous microfragmented lipoaspirate tissue (Lipogems®).\n\nSecondary Purposes: Evaluation of possible radiological changes pre-operative and after 6±1 months by means of MagneticResonanceImage analysis. Symptomatic and functional evaluation at 6±1 months by means of VisualAnalogueScale, KneeSocietyScore, Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC). Reduction of anti-inflammatory drugs (pre-intervention versus 6±1 months). Evaluation "quality-adjusted life years" (QUALY) in relation to the questionnaire SatisfactioForm-12 (pre-intervention vs 6±1 months). Check for any adverse effects directly related to the use of micro-fragmented adipose tissue. Changes in serum levels of biomarkers related to OA (CollagenType II C-Telopeptide (CTX-II), collagen type III N-propeptide (PIIINP)) will be evaluated (pre-intervention vs 6±1 months).\n\nThe study is an interventional, prospective, randomized, controlled trial. Controls: n = 39 patients with knee osteoarthritis undergoing arthroscopic debridement. Cases: n = 39 patients with knee osteoarthritis undergoing arthroscopic debridement surgery + intrarticular injection of autologous microfragmented lipoaspirate tissue (Lipogems®).\n\nSurgical technique: patient in supine position. A double contemporary operating fields is made under sedation. During arthroscopic debridement is made an injection of local anesthetic at the dermal level with a subcutaneous infiltration of Klein solution. The plastic surgeon wait for about 5 minutes for vasoconstriction and then start with liposuction of about 60 ml of adipose tissue. Then lipoaspirate was processed with Lipogems® technique that consist in a mechanical fragmentation, physiological washing and filter passage of the lipoaspirate. A volume of 8-9 ml of microfragmented adipose tissue was injected intra-articulary after arthroscopic debridement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with knee osteoarthritis grade III e IV Kellgren-Lawrence,\n* age between 45 and 75,\n* pain ≥ 6 VAS scale,\n* no ligamentous instability,axial deviation less than 10°\n* BMI between 18 and 30,\n* International Normalized Ratio (INR) \\< 1.5\n\nExclusion Criteria:\n\n* previous traumatic lesion (tibial fracture, osteothomy) of the knee\n* osteonecrosis\n* meniscal surgery in the previous 6 weeks\n* chemiotherapy, radioteherapy\n* diabetes\n* alchoolism, psichiatric disease,drug addiction\n* coagulation disorders\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT04427657', 'briefTitle': 'Use of Lipogems for Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio"}, 'officialTitle': 'Adipose Microfragmented Autologous Tissue for the Treatment of Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'LipoOA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Controls', 'description': '39 patients with knee osteoarthritis undergoing arthroscopic debridement', 'interventionNames': ['Procedure: arthroscopic debridment']}, {'type': 'EXPERIMENTAL', 'label': 'Cases', 'description': '39 patients with knee osteoarthritis undergoing arthroscopic debridement surgery + intrarticular injection of autologous microfragmented lipoaspirate tissue (Lipogems®).', 'interventionNames': ['Procedure: autologous microfragmented lipoaspirate tissue (Lipogems®).']}], 'interventions': [{'name': 'autologous microfragmented lipoaspirate tissue (Lipogems®).', 'type': 'PROCEDURE', 'description': 'patient in supine position. A double contemporary operating fields is made under sedation. During arthroscopic debridement is made an injection of local anesthetic at the dermal level with a subcutaneous infiltration of Klein solution. The plastic surgeon wait for about 5 minutes for vasoconstriction and then start with liposuction of about 60 ml of adipose tissue. Then lipoaspirate was processed with Lipogems® technique that consist in a mechanical fragmentation, physiological washing and filter passage of the lipoaspirate. A volume of 8-9 ml of microfragmented adipose tissue was injected intra-articulary after arthroscopic debridement.', 'armGroupLabels': ['Cases']}, {'name': 'arthroscopic debridment', 'type': 'PROCEDURE', 'description': 'patient in supine position. Under sedation is perform an arthroscopic debridement', 'armGroupLabels': ['Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20161', 'city': 'Milan', 'country': 'Italy', 'facility': 'IRCCS Istituto Ortopedico Galeazzi', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20161', 'city': 'Milan', 'country': 'Italy', 'facility': 'Istituto Ortopedico Galeazzi', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'overallOfficials': [{'name': 'michele ulivi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Istituto Ortopedico GaleazziMilano'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}