Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-01-10 @ 4:17 AM
Study NCT ID:
NCT02480959
Status:
UNKNOWN
Last Update Posted:
2020-03-04
First Post:
2015-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medial Retinacular Plication Versus Medial Patellofemoral Ligament Reconstruction for Recurrent Patellar Instability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C566816', 'term': 'Patella, Familial Recurrent Dislocation Of'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-01', 'studyFirstSubmitDate': '2015-06-08', 'studyFirstSubmitQcDate': '2015-06-22', 'lastUpdatePostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Kujala knee outcome score', 'timeFrame': 'Between two and five years after surgery', 'description': 'A validated international outcome score that evaluates knee functional outcome in relation to patellofemoral symptoms'}], 'secondaryOutcomes': [{'measure': 'International Knee Documentation Committee subjective outcome score', 'timeFrame': 'Between two and five years after surgery', 'description': 'A validated international outcome score that evaluates general knee functional outcome'}, {'measure': 'Tenger activity level score', 'timeFrame': 'Between two and five years after surgery', 'description': 'A validated international outcome score that evaluates highest level of sports activity'}, {'measure': 'Marx activity level score', 'timeFrame': 'Between two and five years after surgery', 'description': 'A validated international outcome score that evaluates highest level of sports activity'}, {'measure': 'Visual Analogue Scale', 'timeFrame': 'Between two and five years after surgery', 'description': 'A validated international scale that evaluates level of pain'}, {'measure': 'Single hop test', 'timeFrame': 'Between two and five years after surgery', 'description': 'Evaluates limb asymmetry index between operated and nonoperated limbs during a single legged hop for distance'}, {'measure': 'Side-to-side hop test', 'timeFrame': 'Between two and five years after surgery', 'description': 'Evaluates limb asymmetry index between operated and nonoperated limbs performing side to side repetaed hops during 30 seconds'}, {'measure': 'Patellar apprehension test', 'timeFrame': 'Between two and five years after surgery', 'description': "Evaluates normal patellar tracking and patient's feeling of subjective comfort while the examiner apply a provocative force that translates the patella lateraly"}, {'measure': 'Infectious event of the operated knee documented by number of events that required antibiotics treatment with or without joint lavage', 'timeFrame': 'Immediately after surgery, for the duration of hospital stay, and until expected time of 1 month', 'description': 'Infection of the surgical site as a severe complication of surgery, requirng antibiotics with or without joint lavage'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Patella, Familial Recurrent Dislocation Of']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether medial patellofemoral ligament reconstruction results in superior functional outcomes compared to medial retinacular plication surgery in cases of recurrent patellar instability.', 'detailedDescription': 'Patients with recurrent lateral patellar instability will be assigned to undergo one of two surgical approaches aimed to prevent recurrent patellar instability and result in improvement in function. One surgical approach will be medial retinacular plication with multiple stitches while the other surgical approach will include medial patellofemoral ligament reconstruction using a hamstring tendon graft. Prior to surgery, and then during follow-up after surgery as well as at the completion of minimum two years follow-up after surgery, patients will be asked to complete subjective functional questionaires that will rate their knee function, and to undergo detailed physical examination and objective functional tests that will quantify the success of surgery. The outcomes of the surgical treatment options will be compared to determine whether medial patellofemoral ligament reconstruction results in superior function and patient subjective satisfaction compared to medial retinacular plication only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recurrent lateral patellar instability has been described by the patient\n\nImaging criteria include:\n\n* TT-TG distance (on CT or MRI) is between 10-20 mm\n* Insall-Salvati Index is between 0.9 - 1.2\n* Trochlea angle is lower than 145 degrees\n\nExclusion Criteria:\n\n* Only a single event of lateral patellar instability occured\n\nImaging criteria include:\n\n* TT-TG distance (on CT or MRI) is below 10 mm or above 20 mm\n* Insall-Salvati Index is below 0.9 or above 1.2\n* Trochlea angle is above 145 degrees\n* Other concomitant intra-articular patholgies, injuries, and surgeries, besides the patella instability, with were recorded at the lower limbs and did not uneventfuly healed, and as a result cause dysfunction of the lower limbs\n* Significant ligamentous injuries of the knees, including cruciate and collateral injuries, as well as meniscal injuries that interfere with function'}, 'identificationModule': {'nctId': 'NCT02480959', 'briefTitle': 'Medial Retinacular Plication Versus Medial Patellofemoral Ligament Reconstruction for Recurrent Patellar Instability', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'Functional Outcome of Surgical Treatment for Recurrent Patellar Instability: A Prospective Comparative Study Between Medial Retinacular Plication Versus Medial Patellofemoral Ligament Reconstruction', 'orgStudyIdInfo': {'id': '0041-15-MMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Medial plication', 'description': 'Patient undergoing surgical treatment for recurrent patellar instability that includes medial retinacular plication', 'interventionNames': ['Procedure: Surgical treatment for recurrent patellar instability']}, {'type': 'OTHER', 'label': 'MPFL reconstruction', 'description': 'Patient undergoing surgical treatment for recurrent patellar instability that includes medial patellofemoral ligament reconstruction using a tendon graft', 'interventionNames': ['Procedure: Surgical treatment for recurrent patellar instability']}], 'interventions': [{'name': 'Surgical treatment for recurrent patellar instability', 'type': 'PROCEDURE', 'description': 'Either medial plication or MPFL reconstructuion surgery', 'armGroupLabels': ['MPFL reconstruction', 'Medial plication']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44281', 'city': 'Kfar Saba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Iftach Hetsroni, M.D.', 'role': 'CONTACT', 'email': 'iftach.hetsroni@clalit.org.il', 'phone': '972-9-7471182'}], 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}], 'centralContacts': [{'name': 'IFTACH HETSRONI, M.D.', 'role': 'CONTACT', 'email': 'iftach.hetsroni@clalit.org.il', 'phone': '972-9-747', 'phoneExt': '1182'}, {'name': 'DROR LINDNER, M.D.', 'role': 'CONTACT', 'email': 'Drorlindner@gmail.com', 'phone': '972-8-977', 'phoneExt': '9443'}], 'overallOfficials': [{'name': 'IFTACH HETSRONI, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meir Medical Center'}, {'name': 'DROR LINDNER, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assaf-Harofeh Medical Center'}, {'name': 'IDAN ILSAR, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah Medical Organization'}, {'name': 'MAZEN FALAH, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}, {'name': 'NASSIM ALKRINAWI, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soroka University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, {'name': 'Soroka University Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}