Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT05270551
Status:
UNKNOWN
Last Update Posted:
2022-03-08
First Post:
2022-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Accelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction With and Without Suture Tape Reinforcement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 114}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-27', 'studyFirstSubmitDate': '2022-02-14', 'studyFirstSubmitQcDate': '2022-02-27', 'lastUpdatePostDateStruct': {'date': '2022-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical outcome', 'timeFrame': '1 year follow up', 'description': 'Tegner Lysholm scores, which assesses activity levels'}, {'measure': 'Clinical outcome', 'timeFrame': '1 year follow up', 'description': 'International Knee Documentation Committee (IKDC) scores which assesses symptoms and function in daily living activities'}], 'secondaryOutcomes': [{'measure': 'Radiological outcome', 'timeFrame': '6 months follow up', 'description': 'Magnetic resonance imaging (MRI) to assess graft healing, ACL tear and graft loosening'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rehabilitation'], 'conditions': ['ACL Injury']}, 'referencesModule': {'references': [{'pmid': '26410092', 'type': 'BACKGROUND', 'citation': 'Schlumberger M, Schuster P, Schulz M, Immendorfer M, Mayer P, Bartholoma J, Richter J. Traumatic graft rupture after primary and revision anterior cruciate ligament reconstruction: retrospective analysis of incidence and risk factors in 2915 cases. Knee Surg Sports Traumatol Arthrosc. 2017 May;25(5):1535-1541. doi: 10.1007/s00167-015-3699-0. Epub 2015 Sep 26.'}, {'pmid': '30945237', 'type': 'BACKGROUND', 'citation': 'Riediger MD, Stride D, Coke SE, Kurz AZ, Duong A, Ayeni OR. ACL Reconstruction with Augmentation: a Scoping Review. Curr Rev Musculoskelet Med. 2019 Jun;12(2):166-172. doi: 10.1007/s12178-019-09548-4.'}, {'pmid': '33128587', 'type': 'BACKGROUND', 'citation': 'Cristiani R, Mikkelsen C, Wange P, Olsson D, Stalman A, Engstrom B. Autograft type affects muscle strength and hop performance after ACL reconstruction. A randomised controlled trial comparing patellar tendon and hamstring tendon autografts with standard or accelerated rehabilitation. Knee Surg Sports Traumatol Arthrosc. 2021 Sep;29(9):3025-3036. doi: 10.1007/s00167-020-06334-5. Epub 2020 Oct 31.'}, {'pmid': '28224069', 'type': 'BACKGROUND', 'citation': 'Smith PA, Bley JA. Allograft Anterior Cruciate Ligament Reconstruction Utilizing Internal Brace Augmentation. Arthrosc Tech. 2016 Oct 10;5(5):e1143-e1147. doi: 10.1016/j.eats.2016.06.007. eCollection 2016 Oct.'}, {'pmid': '19047767', 'type': 'BACKGROUND', 'citation': 'Chmielewski TL, Jones D, Day T, Tillman SM, Lentz TA, George SZ. The association of pain and fear of movement/reinjury with function during anterior cruciate ligament reconstruction rehabilitation. J Orthop Sports Phys Ther. 2008 Dec;38(12):746-53. doi: 10.2519/jospt.2008.2887.'}, {'pmid': '16230470', 'type': 'BACKGROUND', 'citation': 'Beynnon BD, Johnson RJ, Abate JA, Fleming BC, Nichols CE. Treatment of anterior cruciate ligament injuries, part 2. Am J Sports Med. 2005 Nov;33(11):1751-67. doi: 10.1177/0363546505279922.'}, {'type': 'BACKGROUND', 'citation': 'Dean AG. OpenEpi: open source epidemiologic statistics for public health, version 2.3. 1. http://www. openepi. com. 2010.'}]}, 'descriptionModule': {'briefSummary': 'The aim of our study is to evaluate the effect of accelerated rehabilitation post ACL reconstruction with and without augmentation on graft healing and return to normal activity clinically by scoring system and radiologically.', 'detailedDescription': 'ACL reconstruction is the most commonly performed knee ligament reconstruction and employs a variety of surgical techniques. However, despite high success rates, it is still challenged by residual laxity and graft rupture.\n\nWhile the majority of patients who undergo ACLR will have good to excellent results, a subset of patients is at a higher risk for graft failure. For those that require revision surgery, the second operation often fails. Anterior cruciate ligament injuries account for 50% of knee ligament injuries for high school-aged adults.\n\nThe most commonly used autografts for ACLR are the hamstring tendons (HT) and the bone-patellar tendon-bone (BPTB). However, questions remain about how patients with either an HT or a BPTB autograft recover knee muscle strength postoperatively.\n\nTo help address and prevent future ACL failures, new repair and reconstruction techniques have been employed that incorporate suture augmentation. The goal of augmentation is to protect the newly repaired or reconstructed ligament during rehabilitation.\n\nDespite advances in anterior cruciate ligament (ACL) reconstruction surgical techniques and rehabilitation, recent studies report that between 20% to 50% of those with ACL reconstruction do not return to the same sports after surgery and 10% to 70% of those who resume preinjury sports participate at a reduced level or with significant functional impairments.\n\nAnecdotal evidence from patient report and clinical observation suggests that an inability to return to sports after ACL reconstruction can be partially attributed to a fear of reinjuring the knee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 15 to 50 years old.\n* With or without meniscal injury.\n* Isolated ACL injury without any other ligament injury.\n* Recent and chronic injury.\n\nExclusion Criteria:\n\n* Multiligament injury.\n* Deformed knee (Genu varus or valgus).\n* Previous ACL reconstruction or repair.\n* Older than 50 years old and younger than 15 years old.\n* Failed ACL reconstruction or repair -'}, 'identificationModule': {'nctId': 'NCT05270551', 'briefTitle': 'The Effect of Accelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction With and Without Suture Tape Reinforcement', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Effect of Accelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction With and Without Suture Tape Reinforcement', 'orgStudyIdInfo': {'id': 'ACL Recon. rehabilitation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'Without augmentation', 'interventionNames': ['Procedure: ACL Reconstruction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'With augmentation', 'interventionNames': ['Procedure: ACL Reconstruction']}], 'interventions': [{'name': 'ACL Reconstruction', 'type': 'PROCEDURE', 'description': 'All participants will do ACL reconstruction with and without Augmentation and will receive Accelerated rehabilitation program', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohamed Abdel Tawab, Master', 'role': 'CONTACT', 'email': 'mohamedtawab8892@gmail.com', 'phone': '+201022141998'}], 'overallOfficials': [{'name': 'Mohamed Abdel Hamid, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Mohamad Mohamed Abdel-Hamid Morsy'}, {'name': 'Hatem Galal El-Din Zaki, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hatem Galal El-Din Zaki'}, {'name': 'Mohamed Abd El-Radi, Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mohamed Abd El-Radi Abd El-Salam'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mohamed Abdel-Tawab', 'investigatorAffiliation': 'Assiut University'}}}}