Ignite Creation Date:
2025-12-24 @ 3:58 PM
Ignite Modification Date:
2025-12-28 @ 11:39 AM
Study NCT ID:
NCT05701592
Status:
RECRUITING
Last Update Posted:
2023-01-27
First Post:
2023-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Outcomes of Double-bundle Posterior Cruciate Ligament Reconstruction (DB-PCLR)
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': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-25', 'studyFirstSubmitDate': '2023-01-09', 'studyFirstSubmitQcDate': '2023-01-25', 'lastUpdatePostDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee posterior translatory stability - posterior sag test', 'timeFrame': 'At the 12 month of the follow-up.', 'description': 'Posterior sag test will be performed and outcome will be presented as present/ absent'}, {'measure': 'Knee posterior translatory stability - posterior drawer test', 'timeFrame': 'At the 12 month of the follow-up.', 'description': 'Posterior drawer test aided with Rollimeter will be performed and outcomes will be presented in milimeters'}, {'measure': 'Knee posterior translatory stability - posterior Lachman test', 'timeFrame': 'At the 12 month of the follow-up.', 'description': 'Posterior Lachman test aided with Rollimeter will be performed and outcomes will be presented in milimeters'}, {'measure': 'Knee posterior translatory stability - stress X-ray', 'timeFrame': 'At the 12 month of the follow-up.', 'description': 'Stress X-ray assessing posterior translatory stability of the knee will be performed and outcomes will be presented in milimeters'}, {'measure': 'Knee internal rotation stability', 'timeFrame': 'At the 12 month of the follow-up.', 'description': 'Maximal knee internal rotation angle will be assessed with different angles of knee flexion and measured by the means of goniometer and outcomes will be presented in degrees'}, {'measure': 'Knee posterior translatory stability - posterior sag test', 'timeFrame': 'At the 24 month of the follow-up.', 'description': 'Posterior sag test will be performed and outcome will be presented as present/ absent'}, {'measure': 'Knee posterior translatory stability - posterior drawer test', 'timeFrame': 'At the 24 month of the follow-up.', 'description': 'Posterior drawer test aided with Rollimeter will be performed and outcomes will be presented in milimeters'}, {'measure': 'Knee posterior translatory stability - posterior Lachman test', 'timeFrame': 'At the 24 month of the follow-up.', 'description': 'Posterior Lachman test aided with Rollimeter will be performed and outcomes will be presented in milimeters'}, {'measure': 'Knee posterior translatory stability - stress X-ray', 'timeFrame': 'At the 24 month of the follow-up.', 'description': 'Stress X-ray assessing posterior translatory stability of the knee will be performed and outcomes will be presented in milimeters'}, {'measure': 'Knee internal rotation stability', 'timeFrame': 'At the 24 month of the follow-up.', 'description': 'Maximal knee internal rotation angle will be assessed with different angles of knee flexion and measured by the means of goniometer and outcomes will be presented in degrees'}], 'secondaryOutcomes': [{'measure': 'The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)', 'timeFrame': 'At the 12 month of the follow-up.', 'description': 'Min of 0 max of 87 points, higher scores mean a better outcome'}, {'measure': 'The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)', 'timeFrame': 'At the 24 month of the follow-up.', 'description': 'Min of 0 max of 87 points, higher scores mean a better outcome'}, {'measure': 'The functional assessment with the Knee injury and Osteoarthritis Outcome Score (KOOS)', 'timeFrame': 'At the 12 month of the follow-up.', 'description': 'Min of 0 max of 100 points, higher scores mean a better outcome'}, {'measure': 'The functional assessment with the Knee injury and Osteoarthritis Outcome Score (KOOS)', 'timeFrame': 'At the 24 month of the follow-up.', 'description': 'Min of 0 max of 100 points, higher scores mean a better outcome'}, {'measure': 'Retear rate', 'timeFrame': 'At the 12 month of the follow-up.', 'description': 'Rate of patients with retear of the reconstructed ligament'}, {'measure': 'Retear rate', 'timeFrame': 'At the 24 month of the follow-up.', 'description': 'Rate of patients with retear of the reconstructed ligament'}, {'measure': 'ROM', 'timeFrame': 'At the 12 month of the follow-up.', 'description': 'Knee range of motion assessed by the means of goniometer.'}, {'measure': 'ROM', 'timeFrame': 'At the 24 month of the follow-up.', 'description': 'Knee range of motion assessed by the means of goniometer.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Posterior Cruciate Ligament Tear']}, 'referencesModule': {'references': [{'pmid': '28866340', 'type': 'BACKGROUND', 'citation': "Chahla J, Moatshe G, Cinque ME, Dornan GJ, Mitchell JJ, Ridley TJ, LaPrade RF. Single-Bundle and Double-Bundle Posterior Cruciate Ligament Reconstructions: A Systematic Review and Meta-analysis of 441 Patients at a Minimum 2 Years' Follow-up. Arthroscopy. 2017 Nov;33(11):2066-2080. doi: 10.1016/j.arthro.2017.06.049. Epub 2017 Aug 31."}, {'pmid': '36209443', 'type': 'BACKGROUND', 'citation': 'Knapik DM, Gopinatth V, Jackson GR, Chahla J, Smith MV, Matava MJ, Brophy RH. Global variation in isolated posterior cruciate ligament reconstruction. J Exp Orthop. 2022 Oct 9;9(1):104. doi: 10.1186/s40634-022-00541-4.'}, {'pmid': '29953296', 'type': 'BACKGROUND', 'citation': "LaPrade RF, Cinque ME, Dornan GJ, DePhillipo NN, Geeslin AG, Moatshe G, Chahla J. Double-Bundle Posterior Cruciate Ligament Reconstruction in 100 Patients at a Mean 3 Years' Follow-up: Outcomes Were Comparable to Anterior Cruciate Ligament Reconstructions. Am J Sports Med. 2018 Jul;46(8):1809-1818. doi: 10.1177/0363546517750855."}, {'pmid': '30657698', 'type': 'BACKGROUND', 'citation': 'Bernhardson AS, DePhillipo NN, Aman ZS, Kennedy MI, Dornan GJ, LaPrade RF. Decreased Posterior Tibial Slope Does Not Affect Postoperative Posterior Knee Laxity After Double-Bundle Posterior Cruciate Ligament Reconstruction. Am J Sports Med. 2019 Feb;47(2):318-323. doi: 10.1177/0363546518819786. Epub 2019 Jan 18.'}]}, 'descriptionModule': {'briefSummary': "Double-bundle Posterior Cruciate Ligament Reconstruction (DB-PCLR) is becoming increasingly used alternative to the single-bungle PCLR. While more technically challenging, it seems to better improve patients' outcomes. Therefore, outcomes of DB-PCLR will be assessed and reported."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients after PCL tear with knee instability undergoing DB-PCLR', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PCL tear with III grade sympomatic posterior instability confirmed clinically and radiologically\n* full knee range of motion\n\nExclusion Criteria:\n\n* active knee inflammation\n* non-adherence to the study protocol\n* fixed posterior drawer'}, 'identificationModule': {'nctId': 'NCT05701592', 'briefTitle': 'Assessment of Outcomes of Double-bundle Posterior Cruciate Ligament Reconstruction (DB-PCLR)', 'organization': {'class': 'OTHER', 'fullName': 'Artromedical Konrad Malinowski Clinic'}, 'officialTitle': 'Assessment of Outcomes of Double-bundle Posterior Cruciate Ligament Reconstruction (DB-PCLR)', 'orgStudyIdInfo': {'id': '2-pro-ar-2023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with PCL tear treated with DB-PCLR', 'description': 'Patients with PCL tear treated with DB-PCLR', 'interventionNames': ['Procedure: DB-PCLR']}], 'interventions': [{'name': 'DB-PCLR', 'type': 'PROCEDURE', 'description': 'DB-PCLR with reconstruction of both PCL bundles: anterolateral and posteromedial bundle will be performed.', 'armGroupLabels': ['Patients with PCL tear treated with DB-PCLR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97-400', 'city': 'Bełchatów', 'state': 'Łódź Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Konrad Malinowski, MD PhD', 'role': 'CONTACT', 'email': 'malwin8@wp.pl', 'phone': '+48 509 812 212'}], 'facility': 'Artromedical Orthopaedic Clinic', 'geoPoint': {'lat': 51.36883, 'lon': 19.35671}}], 'centralContacts': [{'name': 'Konrad Malinowski, MD PhD', 'role': 'CONTACT', 'email': 'malwin8@wp.pl', 'phone': '+48 509812212'}], 'overallOfficials': [{'name': 'Konrad Malinowski, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Artromedical Orthopaedic Clinic, Bełchatów, Poland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konrad Malinowski MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Konrad Malinowski MD, Director of Artromedical Konrad Malinowski Clinic and Principal Investigator', 'investigatorFullName': 'Konrad Malinowski MD', 'investigatorAffiliation': 'Artromedical Konrad Malinowski Clinic'}}}}