Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-25 @ 8:31 PM
Study NCT ID:
NCT04236492
Status:
RECRUITING
Last Update Posted:
2023-03-16
First Post:
2018-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Protocol to Evaluate Clinical and Imaging Results of Knee Fresh Osteochondral Allografts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2026-11-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-15', 'studyFirstSubmitDate': '2018-07-31', 'studyFirstSubmitQcDate': '2020-01-17', 'lastUpdatePostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'International Knee Documentation Committee (IKDC) Score', 'timeFrame': '15 months', 'description': 'The IKDC is a patient-completed tool, which contains three domains divided on 18 (7 items for symptoms, 1 item for sport participation, 9 items for daily activities, and 1 item for current knee function). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).'}, {'measure': 'Kujala Score', 'timeFrame': '15 months', 'description': 'The Kujala score is a 13-item questionnaire for the patient-reported assessment of anterior knee pain. The Kujala score asks about the ability to do several activities (squatting, stair climbing, running) and also the presence of symptoms/disabilities as noticed by the patient (limping, thigh atrophy, swelling, etc.). The items are summed up to give a total score ranging from 0 to 100, with high scores indicating good outcome.'}, {'measure': 'Western Ontario Meniscal Evaluation Tool (WOMET)', 'timeFrame': '15 months', 'description': 'WOMET is a disease-specific health-related quality of life questionnaire to measure physical symptoms, sports/reaction/work/lifestyle, and emotions of patients with meniscal pathology. It has 16 items representing the domains of physical symptoms (nine items), sports/recreation/work/lifestyle (four items), and emotions (three items). Lower scores indicate better outcome.'}, {'measure': 'Tegner Activity Scale', 'timeFrame': '15 months', 'description': 'Tegner activity level scale is a scale that aims to provide a standardized method of grading work and sporting activities. The patient selects the level of participation that best describes their current level of activity. A score of 0 represents "sick leave or disability pension because of knee problems," whereas a score of 10 corresponds to participation in national and international elite competitive sports. Activity levels 6-10 can only be achieved if the person participates in recreational or competitive sport.'}, {'measure': 'Patient satisfaction', 'timeFrame': '15 months', 'description': 'Patient satisfaction was captured using a 4-item categorical scale, with responses including extremely satisfied (4), satisfied (3), somewhat dissatisfied (2) and dissatisfied (1).'}, {'measure': 'OCAMRISS', 'timeFrame': '15 months', 'description': "MRI will be performed at 9 and 15 months postoperatively. All MRI scans will be assessed by a musculoskeletal radiologist blinded to the patient's medical history and treatment using the OCAMRISS."}, {'measure': 'Bone integration', 'timeFrame': '15 months', 'description': "CT will be performed at 1 day postoperatively and at 3 months postoperatively, 6 months postoperatively and 12 months postoperatively. All CT scans will be assessed by a musculoskeletal radiologist blinded to the patient's medical history and treatment evaluating the subchondral bone and osseous integration. Collimation will be done in all CT to increase image quality and reduce the patient's overall radiation exposure."}], 'secondaryOutcomes': [{'measure': 'Age', 'timeFrame': '15 months', 'description': 'Years'}, {'measure': 'Sex at birth', 'timeFrame': 'baseline', 'description': 'Man or female'}, {'measure': 'IMC', 'timeFrame': 'baseline', 'description': 'kg/m\\^2'}, {'measure': 'Concomitant procedures', 'timeFrame': 'At the surgery', 'description': 'Concomitant procedures (osteotomy, ligamentous repair/reconstruction, meniscal allograft transplantation) are recorded at the time of surgery.'}, {'measure': 'Osteochondral allograft type', 'timeFrame': 'At the surgery', 'description': 'Patellar, femoral or tibial'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fresh osteochondral allografts', 'integration', 'osteochondral defect', 'knee', 'chondral lesion'], 'conditions': ['Osteochondral Defect']}, 'referencesModule': {'references': [{'pmid': '20216470', 'type': 'BACKGROUND', 'citation': "Flanigan DC, Harris JD, Trinh TQ, Siston RA, Brophy RH. Prevalence of chondral defects in athletes' knees: a systematic review. Med Sci Sports Exerc. 2010 Oct;42(10):1795-801. doi: 10.1249/MSS.0b013e3181d9eea0."}, {'pmid': '6174527', 'type': 'BACKGROUND', 'citation': 'Mankin HJ. The response of articular cartilage to mechanical injury. J Bone Joint Surg Am. 1982 Mar;64(3):460-6. No abstract available.'}, {'pmid': '24486758', 'type': 'BACKGROUND', 'citation': 'Sherman SL, Garrity J, Bauer K, Cook J, Stannard J, Bugbee W. Fresh osteochondral allograft transplantation for the knee: current concepts. J Am Acad Orthop Surg. 2014 Feb;22(2):121-33. doi: 10.5435/JAAOS-22-02-121.'}, {'pmid': '17428666', 'type': 'BACKGROUND', 'citation': 'Widuchowski W, Widuchowski J, Trzaska T. Articular cartilage defects: study of 25,124 knee arthroscopies. Knee. 2007 Jun;14(3):177-82. doi: 10.1016/j.knee.2007.02.001. Epub 2007 Apr 10.'}, {'pmid': '10028117', 'type': 'BACKGROUND', 'citation': 'Bugbee WD, Convery FR. Osteochondral allograft transplantation. Clin Sports Med. 1999 Jan;18(1):67-75. doi: 10.1016/s0278-5919(05)70130-7.'}, {'pmid': '3042234', 'type': 'BACKGROUND', 'citation': 'Oakeshott RD, Farine I, Pritzker KP, Langer F, Gross AE. A clinical and histologic analysis of failed fresh osteochondral allografts. Clin Orthop Relat Res. 1988 Aug;(233):283-94.'}, {'pmid': '2324145', 'type': 'BACKGROUND', 'citation': 'Czitrom AA, Keating S, Gross AE. The viability of articular cartilage in fresh osteochondral allografts after clinical transplantation. J Bone Joint Surg Am. 1990 Apr;72(4):574-81.'}, {'pmid': '17200323', 'type': 'BACKGROUND', 'citation': 'Maury AC, Safir O, Heras FL, Pritzker KP, Gross AE. Twenty-five-year chondrocyte viability in fresh osteochondral allograft. A case report. J Bone Joint Surg Am. 2007 Jan;89(1):159-65. doi: 10.2106/JBJS.E.00815. No abstract available.'}, {'pmid': '11274532', 'type': 'BACKGROUND', 'citation': 'Sirlin CB, Brossmann J, Boutin RD, Pathria MN, Convery FR, Bugbee W, Deutsch R, Lebeck LK, Resnick D. Shell osteochondral allografts of the knee: comparison of mr imaging findings and immunologic responses. Radiology. 2001 Apr;219(1):35-43. doi: 10.1148/radiology.219.1.r01ap0435.'}, {'pmid': '18465182', 'type': 'BACKGROUND', 'citation': 'Gross AE, Kim W, Las Heras F, Backstein D, Safir O, Pritzker KP. Fresh osteochondral allografts for posttraumatic knee defects: long-term followup. Clin Orthop Relat Res. 2008 Aug;466(8):1863-70. doi: 10.1007/s11999-008-0282-8. Epub 2008 May 9.'}, {'pmid': '16523140', 'type': 'BACKGROUND', 'citation': 'Torga Spak R, Teitge RA. Fresh osteochondral allografts for patellofemoral arthritis: long-term followup. Clin Orthop Relat Res. 2006 Mar;444:193-200. doi: 10.1097/01.blo.0000201152.98830.ed.'}, {'pmid': '10101321', 'type': 'BACKGROUND', 'citation': 'Chu CR, Convery FR, Akeson WH, Meyers M, Amiel D. Articular cartilage transplantation. Clinical results in the knee. Clin Orthop Relat Res. 1999 Mar;(360):159-68.'}, {'pmid': '16056047', 'type': 'BACKGROUND', 'citation': 'Jamali AA, Emmerson BC, Chung C, Convery FR, Bugbee WD. Fresh osteochondral allografts: results in the patellofemoral joint. Clin Orthop Relat Res. 2005 Aug;(437):176-85.'}, {'pmid': '6699046', 'type': 'BACKGROUND', 'citation': 'Locht RC, Gross AE, Langer F. Late osteochondral allograft resurfacing for tibial plateau fractures. J Bone Joint Surg Am. 1984 Mar;66(3):328-35.'}, {'pmid': '12721343', 'type': 'BACKGROUND', 'citation': 'Shasha N, Krywulak S, Backstein D, Pressman A, Gross AE. Long-term follow-up of fresh tibial osteochondral allografts for failed tibial plateau fractures. J Bone Joint Surg Am. 2003;85-A Suppl 2:33-9. doi: 10.2106/00004623-200300002-00005.'}, {'pmid': '15317888', 'type': 'BACKGROUND', 'citation': 'Zou S, Dodd RY, Stramer SL, Strong DM; Tissue Safety Study Group. Probability of viremia with HBV, HCV, HIV, and HTLV among tissue donors in the United States. N Engl J Med. 2004 Aug 19;351(8):751-9. doi: 10.1056/NEJMoa032510.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to assess the clinical and radiological results after carrying out a transplant of fresh osteochondral allograft in the knee.', 'detailedDescription': 'Fresh osteochondral allograft transplantation allows treatment of large osteochondral lesions of the knee in young patients. Real-world, patient-centered data on clinical and imaging results after fresh osteochondral allograft transplantation are needed.\n\nThis study is a prospective, observational, unicenter, patient-centered outcomes research study. Patients undergoing cartilage repair with fresh osteochondral allograft transplantation for osteochondral knee lesions are eligible to participate.\n\nClinical results are evaluated from baseline to 3 months, 6 months, 9 months, 12 months and 15 months postoperatively. At each time point, participants respond to several patient-reported outcome instruments to measure clinical results (IKDC, Kujala, Womet and Tegner) and patient satisfaction is captured.\n\nImaging results are evaluated with MRI (9 months and 15 months postoperatively) using the OCAMRISS evaluating cartilage features, bone features and ancillary features; and with CT (1 day, 3 months, 6 months and 12 months postoperatively) evaluating subchondral bone and osseous integration.\n\nVariations will be explored using additional or alternative covariates such as concomitant surgery procedures, osteochondral allograft morphology, age, sex at birth, IMC, living situation and employment status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Specialized care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients undergoing cartilage repair with fresh osteochondral allograft transplantation for large focal full-thickness chondral and osteochondral defects (\\>2 cm2) on the tibial plateau, femoral condyles, trochlea and/or patella Bipolar lesions are included.\n\nExclusion Criteria:\n\n* BMI\\> 30 kg / m2\n* Systemic inflammatory diseases\n* Inflammatory arthritis\n* Advanced osteoarthritis\n* Tricompartmental degenerative process\n* Active infection\n* Patients who are unable to provide written informed consent.'}, 'identificationModule': {'nctId': 'NCT04236492', 'briefTitle': 'Study Protocol to Evaluate Clinical and Imaging Results of Knee Fresh Osteochondral Allografts', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Study Protocol for a Prospective Observational Study to Evaluate the Clinical and Imaging Results of the Fresh Osteochondral Allograft Transplantation for Osteochondral Knee Lesions', 'orgStudyIdInfo': {'id': 'IIBSP-ALO-2018-21'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fresh osteochondral allografting', 'description': 'Transplantation of a fresh osteochondral allograft in the knee', 'interventionNames': ['Procedure: Fresh osteochondral allografting']}], 'interventions': [{'name': 'Fresh osteochondral allografting', 'type': 'PROCEDURE', 'description': 'Transplantation of a fresh osteochondral allograft in the knee', 'armGroupLabels': ['Fresh osteochondral allografting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08026', 'city': 'Barcelona', 'state': 'Catalonia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'role': 'CONTACT', 'phone': '932919000'}, {'name': 'Aránzazu González-Osuna', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Eduard Ramírez Bermejo', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Àlex Grau Blanes', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Àlex Grau Blanes', 'role': 'CONTACT', 'email': 'agraub@santpau.cat', 'phone': '+34935537031'}, {'name': 'Aránzazu González-Osuna', 'role': 'CONTACT', 'email': 'agonzalezo@santpau.cat', 'phone': '+34935537031'}], 'overallOfficials': [{'name': 'Pablo Gelber', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'collaborators': [{'name': 'Banc de Sang i Teixits', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}