Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-26 @ 2:29 AM
Study NCT ID:
NCT03505359
Status:
UNKNOWN
Last Update Posted:
2018-05-11
First Post:
2017-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rehabilitation Protocol for Reconstruction of Anterior Cruciate Ligament and Anterolateral Knee Ligament Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A blinded randomized clinical trial will be conducted to evaluate the effects of two protocols for the rehabilitation of patients undergoing combined re-construction of ACL and ALL.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2019-12-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-03', 'studyFirstSubmitDate': '2017-10-03', 'studyFirstSubmitQcDate': '2018-04-12', 'lastUpdatePostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee Function', 'timeFrame': '12 months', 'description': 'Lysholm Knee Scoring Scale: instrument consisting of eight domains: limping, support, re-straining, instability, pain, swelling, climbing stairs and squatting, with closed-answers alternatives. The final result is expressed in nominal and ordinal form, being "excellent" ranging from 95 to 100 points; "Good" from 84 to 94 points; "Regular" between 65 and 83 and "bad" when values are equal to or less than 64.'}], 'secondaryOutcomes': [{'measure': 'Follow-up of knee function', 'timeFrame': '3 weeks; 6 weeks; 12 weeks; 6 months', 'description': 'Lysholm Knee Scoring Scale: instrument consisting of eight domains: limping, support, re-straining, instability, pain, swelling, climbing stairs and squatting, with closed-answers alternatives. The final result is expressed in nominal and ordinal form, being "excellent" ranging from 95 to 100 points; "Good" from 84 to 94 points; "Regular" between 65 and 83 and "bad" when values are equal to or less than 64.'}, {'measure': 'Static Postural Control', 'timeFrame': '3 weeks; 6 weeks; 12 weeks; 6 months and 12 months', 'description': 'Static Postural Control will be assessed through the AccuSuway mobile power platform.(AMTI®).'}, {'measure': 'Dynamic Postural Control', 'timeFrame': '3 weeks; 6 weeks; 12 weeks; 6 months and 12 months', 'description': 'Dynamic Postural Control will be assessed through the Balance Master System (BMS) platform.'}, {'measure': 'Muscle strength', 'timeFrame': '3 weeks; 6 weeks; 12 weeks; 6 months and 12 months', 'description': 'The isometric and isokinetic strength test will be performed by an isokinetic dynamometry (Biodex Multi-Joint System III), used to record the torque of the knee flexor and extensor muscles, as well as the hip abductors.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anterior Cruciate Ligament Reconstruction', 'Anterolateral Ligament Reconstruction', 'Rehabilitation']}, 'descriptionModule': {'briefSummary': 'Introduction: Individuals with an ACL lesion present abnormal rotational stability. Among the structures located in the anterolateral region of the knee that could act as restraints of the rotational knee lassitude, there is the Anterior Lateral Ligament (ALL), and its reconstruction associated with ACL reconstruction could reduce recurrence injury rates. Objective: to develop a rehabilitation protocol for patients undergoing combined reconstruction of ACL and ALL. METHOD: Articles published with patients submitted to ACL reconstruction with an anatomic technique and flexor tendon graft, (which is the same one adopted in this study), were selected as a base to this protocol. Discussion: The results will provide important information on clinical practice, since it can help identify the necessity or not of restraining the knee range of motion in combined surgeries. It can guide the therapeutic planning, including the cost of knee restraint devices, in addition to estimating these patients prognosis. The protocol with partial restriction of knee range of motion in the first 6 weeks of postoperative is the most indicated program in the rehabilitation of the combined surgeries of ACL and ALL reconstruction.', 'detailedDescription': 'Currently, the anatomical reconstruction of the ACL has been widely used, with the purpose of increasing the knee rotational control after the injury, and thus, to improve the clinical evolution in the long term. The concept involves restoring knee kinematics by improving function by reducing the number of graft failures, delaying or preventing degeneration of the joint. Normally, rehabilitation protocols in these cases are more careful with respect to knee ROM gain and use of exercises in open kinetic chain, with the purpose of preserving the graft.\n\nAllied to this concept, the use of extra-articular reconstruction associated with ACL reconstruction, gained new horizons with the discovery of ALL, signaling to the possibility of a better rotational control and, consequently, a decrease in the number of graft failures.\n\nDue to the particularities of each surgical technique, it is necessary that the rehabilitation protocols adapt to the different methods, guaranteeing the functional recovery, but without damages to the reconstruction.\n\nWith the proposal of ACL reconstruction surgery associated with ALL reconstruction, it is necessary to develop a specific rehabilitation protocol for these patients, considering some postoperative specificities of extra-articular reconstructions, since they are data that are not available in the literature until now.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Only male individuals will be selected to avoid physiological differences between genders, such as muscle strength, flexibility and ligamentous laxity.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males\n* Aged from 18 to 40 years\n* Documented and symptomatic anterior cruciate ligament (ACL) injury followed by ACL+ anterolateral ligament (ALL) ligament reconstruction\n\nExclusion Criteria:\n\n* Patients with multiple ligament injuries\n* Bilateral ACL injury'}, 'identificationModule': {'nctId': 'NCT03505359', 'briefTitle': 'Rehabilitation Protocol for Reconstruction of Anterior Cruciate Ligament and Anterolateral Knee Ligament Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Post-operative Rehabilitation Protocol for Combined Reconstruction of Anterior Cruciate Ligament and Anterolateral Knee Ligament Surgery', 'orgStudyIdInfo': {'id': '54541116.8.0000.0068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Group treated by the new protocol with partial knee immobilization', 'interventionNames': ['Other: partial knee immobilization protocol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Group treated by a standard protocol for ACL reconstruction.', 'interventionNames': ['Other: standard ACL reconstruction rehabilitation protocol']}], 'interventions': [{'name': 'partial knee immobilization protocol', 'type': 'OTHER', 'description': '12 weeks rehabilitation protocol including exercises to improve range of motion, gait, balance, muscle strength with a 0-60 degrees articulated knee brace in the first 6 weeks in the experimental group.', 'armGroupLabels': ['Experimental group']}, {'name': 'standard ACL reconstruction rehabilitation protocol', 'type': 'OTHER', 'description': '12 weeks rehabilitation protocol including exercises to improve range of motion, gait, balance, muscle strength.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Silvia M João, PhD', 'role': 'CONTACT', 'email': 'smaj@usp.br', 'phone': '55 11 3091-8424'}], 'facility': 'USaoPauloGH', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Silvia M João, PhD', 'role': 'CONTACT', 'email': 'smaj@usp.br', 'phone': '55 11 30918424'}, {'name': 'Juliana f Sauer, Master', 'role': 'CONTACT', 'email': 'juliana.sauer@usp.br', 'phone': '55 11 30918424'}], 'overallOfficials': [{'name': 'Silvia M João, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is not a plan to make IPD available until the protocol is published'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Silvia Maria Amado João', 'investigatorAffiliation': 'University of Sao Paulo General Hospital'}}}}