Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:29 PM
Study NCT ID:
NCT07377669
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-01-30
First Post:
2026-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Retrospective and Prospective Study: Monocompartimental Knee Arthroplasty Combined With Anterior Cruciate Ligament Reconstruction Surgery - a Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-22', 'studyFirstSubmitDate': '2026-01-09', 'studyFirstSubmitQcDate': '2026-01-22', 'lastUpdatePostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tegner-Lysholm score', 'timeFrame': '12 months after surgery', 'description': 'The Tegner Lysholm Knee Scoring Scale is a questionnaire used to assess knee function and symptoms, particularly in the context of ligament injuries of the knee. It evaluates eight categories: pain, swelling, instability, locking, limp, stair climbing, squatting, and need for support. Each category is scored, and the total score, out of 100, reflects overall knee function. Higher scores indicate better knee function.'}], 'secondaryOutcomes': [{'measure': 'SF-36', 'timeFrame': '12 months after surgery', 'description': "It consists of 36 questions assessing the patient's general health, divided into eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, emotional role, and mental health. The score ranges from a minimum of 0 to a maximum of 100 and has been validated in Italian."}, {'measure': 'Ucla', 'timeFrame': '12 months after surgery', 'description': 'It is a questionnaire used to define activity levels after knee arthroplasty. It is patient-reported and provides a score ranging from 1 to 10. It has also been validated in Italian.'}, {'measure': 'Return to Sport', 'timeFrame': '12 months after surgery', 'description': 'Number of months elapsed before returning to sports activity (if resumed). Sports activities are classified according to Veil et al. into low-intensity, potentially low-intensity, intermediate-intensity, and high-intensity categories.'}, {'measure': 'New KSS', 'timeFrame': '12 months after surgery', 'description': 'A self-administered knee function and outcome assessment test. Validation in Italian is still ongoing.'}, {'measure': 'Vas', 'timeFrame': '12 months after surgery', 'description': 'Subjective pain assessment scale'}, {'measure': 'KT-1000', 'timeFrame': '12 months after surgery', 'description': 'An objective tool for assessing anteroposterior knee laxity'}, {'measure': 'ROM', 'timeFrame': '12 months after surgery', 'description': 'Active and passive range of motion'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Knee Arthritis Osteoarthritis', 'Cruciate Ligament Rupture']}, 'descriptionModule': {'briefSummary': 'This study aims to collect datas about patient who underwent simultaneous monocompartimental knee replacement and anterior cruciate ligament recontruction', 'detailedDescription': 'The aim is to understand if anterior cruciate ligament recontruction is mandatory in case of monocompartimental knee replacement, given the fact that anterior stability could be compromised at first in ACL (anterior cruciate ligament) deficient knees. Current datas in literature are not sufficient to establish if ACL must always be recontructed or if only in some cases'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients affected by monocompartimental knee arthosis and ACL complete lesion in the same knee who underwent simoultaneous one stage ACLr + UKA', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* monocompartimental knee arthrosis and ACL complete lesion\n* High functional request\n* Follow up \\>12 m\n* Complete clinical and radiographic documentation\n* Patients who accepted to partecipate to the study\n* Patients who did non underwent surgical procedures in the controlateral knee\n\nExclusion Criteria:\n\n* two stage surgeries (UKA and ACLr)\n* patients affected by neuromuscolar disorders, or psychomotor disorders\n* further knee ligamentous associated lesions\n* revision surgery\n* low functional request due to comorbilities'}, 'identificationModule': {'nctId': 'NCT07377669', 'acronym': 'MONO-LCA', 'briefTitle': 'A Retrospective and Prospective Study: Monocompartimental Knee Arthroplasty Combined With Anterior Cruciate Ligament Reconstruction Surgery - a Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': 'A Retrospective and Prospective Study: Monocompartimental Knee Arthroplasty Combined With Anterior Cruciate Ligament Reconstruction Surgery - a Pilot Study', 'orgStudyIdInfo': {'id': 'MONO-LCA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'UKA + LCA patients', 'description': 'Patients who underwent simultaneous anterior cruciate ligament and monocompartimental knee replacement', 'interventionNames': ['Procedure: UKA + ACLr']}], 'interventions': [{'name': 'UKA + ACLr', 'type': 'PROCEDURE', 'description': 'Simultaneous ACL reconstruction and Unicompartmental Knee Arthroplasty', 'armGroupLabels': ['UKA + LCA patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40127', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Istituto Ortopedico Rizzoli', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Stefano Zaffagnini, Full Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istituto Ortopedico Rizzoli'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Stefano Zaffagnini', 'investigatorAffiliation': 'Istituto Ortopedico Rizzoli'}}}}