Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT04838158
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2021-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Knee Flexor Muscles Strength in Patients With Patellar Instability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2016-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-06', 'studyFirstSubmitDate': '2021-03-22', 'studyFirstSubmitQcDate': '2021-04-06', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hamstrings peak torque', 'timeFrame': 'up to 18 months', 'description': 'measured on Biodex System'}, {'measure': 'torque in 30 degrees of the knee flexion', 'timeFrame': 'up to 18 months', 'description': 'measured on Biodex System'}, {'measure': 'angle of peak torque', 'timeFrame': 'up to 18 months', 'description': 'measured on Biodex System'}, {'measure': 'peak torque hamstring to quadriceps ratio (H/Q ratio)', 'timeFrame': 'up to 18 months', 'description': 'measured on Biodex System'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patella Dislocation Recurrent', 'Children, Only']}, 'referencesModule': {'references': [{'pmid': '34454460', 'type': 'DERIVED', 'citation': 'Malecki K, Fabis J, Flont P, Fabis-Strobin A, Niedzielski K. Assessment of knee flexor muscles strength in patients with patellar instability and its clinical implications for the non-surgical treatment of patients after first patellar dislocation - pilot study. BMC Musculoskelet Disord. 2021 Aug 28;22(1):740. doi: 10.1186/s12891-021-04636-4.'}]}, 'descriptionModule': {'briefSummary': 'The study enrolled 33 patients with confirmed recurrent patellar dislocation, including 6 patients with bilateral involvement. In the study group, both side hamstring muscle were evaluated at the velocities of 60 and 180 deg/s for the following parameters: peak torque, torque in 30 degree of the knee flexion, angle of peak torque and peak torque hamstring to quadriceps ratio (H/Q ratio).', 'detailedDescription': "The study enrolled 33 patients with confirmed recurrent patellar dislocation, including 6 patients with bilateral involvement. The study group consisted of 20 girls and 13 boys with average age at the time of the study 16.2 years (range: 8 to 17 years, SD 2.7). For the purpose of the study, a control group of 18 healthy subjects (12 girls and 6 boys) aged on the average 15.7 years (range:13 to 17 years, SD 1.5), was recruited.\n\nThe following study inclusion criteria were applied: recurrent patellar dislocation, correctly completed testing protocol, age under 18 years at the time of testing. Subjects with osteochondral fracture and those with a history of the knee surgery were excluded.\n\nEach patient underwent an isokinetic examination on Biodex System 3 (Biodex Multi-Joint System - Pro, Biodex Medical Systems, Inc. New York, USA). In the study group, both side hamstring muscle were evaluated at the velocities of 60 and180 deg/s for the following parameters: peak torque (PT), torque in 30 degree of the knee flexion (T 30 deg.), angle of peak torque (APT) and peak torque hamstring to quadriceps ratio (H/Q ratio).\n\nIsokinetic measurements were made by a trained, experienced physiotherapist. After a proper warm-up and instruction, the test performed 10 full repetitions, the best result was recorded. The results of the peak torque (PT) of both test and control limbs were then compared with the normative data for age and gender available in the literature. In addition, we compared the peak torque (PT), torque in 30 degrees of the knee flexion (T 30 deg.), angle of peak torque (APT) and peak torque hamstring to quadriceps ratio (H/Q ratio) of involved and uninvolved knee flexor strength in the study group. Depending on the data distribution, the nonparametric Wilcoxon's test or the parametric t-test for the related data was applied. Statistical significance was assumed for p\\<0.05. The study was approved by our Institutional Review Board. Informed consent was obtained and the rights of subjects were protected."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* recurrent patellar dislocation,\n* correctly completed testing protocol,\n* age under 18 years at the time of testing\n\nExclusion Criteria:\n\n* osteochondral fracture\n* those with a history of the knee surgery'}, 'identificationModule': {'nctId': 'NCT04838158', 'briefTitle': 'Assessment of Knee Flexor Muscles Strength in Patients With Patellar Instability', 'organization': {'class': 'OTHER', 'fullName': 'Polish Mother Memorial Hospital Research Institute'}, 'officialTitle': 'Assessment of Knee Flexor Muscles Strength in Patients With Patellar Instability and Its Clinical Implication in Non-surgical Treatment of Patients After First Patella Dislocation.', 'orgStudyIdInfo': {'id': 'PolishMMHRI 23/06/2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention group', 'description': 'Those cases who underwent operative treatment and isokinetics evaluation.', 'interventionNames': ['Diagnostic Test: Isokinetic measurements']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'Those who were control group of healthy subjects to compare to normative data', 'interventionNames': ['Diagnostic Test: Isokinetic measurements']}], 'interventions': [{'name': 'Isokinetic measurements', 'type': 'DIAGNOSTIC_TEST', 'description': 'Each patient underwent an isokinetic examination on Biodex System 3 (Biodex Multi-Joint System - Pro, Biodex Medical Systems, Inc. New York, USA). In the study group, both side hamstring muscle were evaluated at the velocities of 60 and180 deg/s for the following parameters: peak torque (PT), torque in 30 degree of the knee flexion (T 30 deg.), angle of peak torque (APT) and peak torque hamstring to quadriceps ratio (H/Q ratio).', 'armGroupLabels': ['Control group', 'Intervention group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Krzysztof Małecki, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': "Polish Mother's Memorial Hospital Research Institute"}, {'name': 'Jarosław Fabiś, prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical University of Lodz'}, {'name': 'Paweł Flont, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Polish Mother's Memorial Hospital Research Institute"}, {'name': 'Anna Fabiś-Strobin, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Polish Mother's Memorial Hospital Research Institute"}, {'name': 'Kryspin Niedzielski, prof.', 'role': 'STUDY_CHAIR', 'affiliation': "Polish Mother's Memorial Hospital Research Institute"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'April 2021 - December 2023', 'ipdSharing': 'YES', 'description': 'Research protocol, personal results, informed consent', 'accessCriteria': 'Upon reasonable request on e-mail krzynormal@wp.pl'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Polish Mother Memorial Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}