Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-01-02 @ 10:11 AM
Study NCT ID:
NCT07125794
Status:
RECRUITING
Last Update Posted:
2025-08-15
First Post:
2025-08-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Original Denis Brawn Brace Versus Its Modification for Management of Relapsed Idiopathic Clubfoot Following Ponseti Casting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-10', 'studyFirstSubmitDate': '2025-08-10', 'studyFirstSubmitQcDate': '2025-08-10', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Parents' compliance", 'timeFrame': '12 months post-procedure', 'description': "Parents' compliance will be classified into three grades as follows:\n\n* Grade 0: poor follow-up with a lack of commitment in bracing hours (bad compliance).\n* Grade 1: an intermittent follow-up with a good commitment in bracing hours (intermediate compliance).\n* Grade 2: a good follow-up with a strict commitment in bracing hours (good compliance)."}], 'secondaryOutcomes': [{'measure': 'Efficacy in maintaining correction measured by the Pirani score', 'timeFrame': '12 months post-procedure', 'description': 'The Pirani scoring system is reliable, quick, and easy to use, and provides a good forecast about the likely treatment for an individual foot. It involves evaluating six clinical signs of contracture, with scores ranging from 0 to 1 for each sign, and a higher score indicating a more severe deformity.\n\nAll the patients treated will undergo thorough evaluation to find out other systemic diseases, and grading of the feet as per the modified Pirani scoring system.'}, {'measure': 'Incidence of complications', 'timeFrame': '12 months post-procedure', 'description': 'Incidence of complications will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Denis Brawn Brace', 'Modification', 'Management', 'Idiopathic Clubfoot', 'Ponseti Casting']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the effectiveness of the original Denis Brawn brace to its modification in managing relapsed idiopathic clubfoot in patients following Ponseti casting.', 'detailedDescription': 'Clubfoot is an intricate deformity of the ankle and foot involving bony malalignment, adduction of the forefoot, and hindfoot varus, cavus, and equinus caused by contracture of soft tissues.\n\nLack of compliance causes the majority of relapse, as the child may have problems sleeping and wearing the Dennis Brown Splint; that is why parental counseling is vital and very much important in this regard.\n\nBracing plays a vital role in the maintenance of corrected club foot and allows the foot to achieve normal position after tenotomy, followed by serial casting. Bracing holds the foot not in a corrected but in an overcorrected position so that the normal position of the foot could be achieved after the correction. Without bracing, it is almost impossible for the physician or the surgeon to maintain the correction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This retrospective study will be carried out on 60 patients with idiopathic clubfoot after approval from the institutional ethical committee.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 2 to 5 years.\n* Both sexes.\n* Relapsed cases.\n* Patients with idiopathic clubfoot.\n\nExclusion Criteria:\n\n* Neurological or syndromic involvement.\n* Presenting with skin or soft-tissue lesions around the foot and ankle.\n* Inadequate documentation.\n* Soft-tissue surgery is needed (except tendo-achilles tenotomy).\n* Irregular plaster casting schedule.'}, 'identificationModule': {'nctId': 'NCT07125794', 'briefTitle': 'Original Denis Brawn Brace Versus Its Modification for Management of Relapsed Idiopathic Clubfoot Following Ponseti Casting', 'organization': {'class': 'NETWORK', 'fullName': 'The General Authority for Teaching Hospitals and Institutes'}, 'officialTitle': 'The Original Denis Brawn Brace Versus Its Modification for Management of Relapsed Idiopathic Clubfoot Following Ponseti Casting: A Retrospective Study.', 'orgStudyIdInfo': {'id': 'HAH00072'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group I', 'description': 'Patients who were managed with the original Denis Browne splint.', 'interventionNames': ['Procedure: Original Denis Browne splint']}, {'label': 'Group II', 'description': 'Patients who were managed with the modified Denis Browne splint.', 'interventionNames': ['Procedure: Modified Denis Browne splint']}], 'interventions': [{'name': 'Original Denis Browne splint', 'type': 'PROCEDURE', 'description': 'Patients who were managed with the original Denis Browne splint.', 'armGroupLabels': ['Group I']}, {'name': 'Modified Denis Browne splint', 'type': 'PROCEDURE', 'description': 'Patients who were managed with the modified Denis Browne splint.', 'armGroupLabels': ['Group II']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mahmoud M Abdallah, MD', 'role': 'CONTACT', 'email': 'Mma-ortho@hotmail.com', 'phone': '00201006194146'}], 'facility': 'General Authority for Teaching Hospitals and Institutes', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mahmoud M Abdallah, MD', 'role': 'CONTACT', 'email': 'Mma-ortho@hotmail.com', 'phone': '00201006194146'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The General Authority for Teaching Hospitals and Institutes', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Orthopedic Surgery', 'investigatorFullName': 'Mahmoud Mohamed Abdallah', 'investigatorAffiliation': 'The General Authority for Teaching Hospitals and Institutes'}}}}