[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628776":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":21,"studyPopulation":13,"armGroups":22,"interventions":34,"overallOfficials":13,"centralContacts":42,"locations":13,"responsibleParty":48,"collaborators":13,"id":52,"slug":13,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":13,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":13,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":13,"overallStatus":70,"whyStopped":13,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":13},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"To compare the results of the two technical procedures of surgical treatment by Radiological correction","radiological correction assessed using the Demiglio score to evaluate the outcome of the two surgical techniques.","6 months after surgery",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":18,"observationalModel":13,"timePerspective":13,"maskingInfo":19},"RANDOMIZED","SEQUENTIAL","* Full history taking\n* Clinical examination with gait assessment (video assisted)\n* Radiological evaluation will be performed using standardized anteroposterior and lateral foot radiographs. Measurements included the talo-first metatarsal angle, calcaneo-fifth metatarsal angle, talocalcaneal angle, and Meary's angle. Radiographs will be obtained preoperatively and during follow-up. The pre- and latest follow up after full correction radiographic parameters of each enrolled patient will be compared separately.\n\nOperative procedure:\n\nIn this study, patients will be divided into two groups randomly. Group1: Midfoot Osteotomy for Residual Metatarsal Adducts Group 2: Guided Growth Using 8-Plate Epiphysiodesis","TREATMENT",{"masking":20,"maskingDescription":13,"whoMasked":13},"NONE","Congenital Talipes Equinovarus (CTEV) is a significant musculoskeletal deformity affecting children globally. It is characterized by hindfoot varus, midfoot cavus, forefoot adduction, and ankle equines (1). The Ponseti method has proven to be highly effective and is now the gold standard for treatment. However, long-term follow-up studies indicate a variable relapse rate. Timely diagnosis of relapse is crucial, underscoring the importance of regular follow-up visits (2).\n\nNowadays the method has replaced the surgery and served as the gold standard for the treatment of congenital clubfoot in pediatric orthopedics(3) . However, it is still challenging to treat severe cases such as neglected or relapsed clubfoot in older children(4). Among the deformities, residual forefoot adduction with supination after treatment is a common issue which is also referred to as the \"bean-shaped foot\"( 5) . According to Jasiewicz et.al study, the combination of a cuboid closing with a cuneiform opening wedge osteotomy or with a trans-midfoot osteotomy is currently the most popular procedure to correct the residual forefoot adduction(6).\n\nHowever, complications such as neurovascular lesion, non-union or permanent foot stiffness might occur as a result of the operation. In addition, the tarsal growth plate and cartilaginous area could be compromised due to the difficulty in manipulating the osteotomy and fixation process(7). 8-plate is one of the major methods that gained popularity quickly due to temporary growth impediment of the physis without damaging it irreversibly, and is suitable for a variety of indications including different plane deformities around the knee and limb length discrepancies(8). However, there are a few reports regarding 8-plates in individuals with clubfoot deformities. Recently, guided growth techniques using temporary epiphysiodesis (8 -plate) have been introduced as a minimally invasive alternative that allows gradual correction by modulating growth.However, high-quality comparative clinical evidence between these two techniques is lacking.\n\nThe current research is the first one to compare the clinical, radiological, and patient satisfaction outcome of midfoot osteotomy versus eight -Plate epiphysiodesis for residual metatarsal adductus in relapsed clubfoot.The purpose of this prospective study is to show the best technique to achieve patient satisfaction.",[23,29],{"label":24,"type":25,"description":26,"interventionNames":27},"Midfoot Osteotomy","ACTIVE_COMPARATOR","A closing wedge osteotomy of the cuboid will be performed using an oscillating saw, with the wedge size determined according to the severity of forefoot adduction.",[28],"Procedure: Midfoot Osteotomy",{"label":30,"type":25,"description":31,"interventionNames":32},"8-Plate Epiphysiodesis","A guidewire will be inserted to confirm proper positioning. A tension-band eight-plate was will then be placed bridging the lateral side of the calcaneocuboid region, with two cannulated 3.5 mm screws inserted-one into the cuboid and one into the calcaneus-ensuring central placement within the cuboid to modulate lateral column growth.",[33],"Procedure: 8-Plate Epiphysiodesis",[35,39],{"type":36,"name":24,"description":37,"armGroupLabels":38,"otherNames":13},"PROCEDURE","Group 1 Immobilization in along leg (above knee cast) for 6 weeks Non-weight bearing during casting period Cast removal followed by gradual return to weight bearing",[24],{"type":36,"name":30,"description":40,"armGroupLabels":41,"otherNames":13},"NO immobilization, only protective splinting for 2 weeks as postoperative rest, after splint removal return to normal activity. Plate will be removed after full clinical and radiological correction. Further procedures e.g. tibalis anterior tendon transfer can be done as needed.",[30],[43],{"name":44,"role":45,"phone":46,"phoneExt":13,"email":47},"Mahmoud Ali Hassan, specialist","CONTACT","01062637403","mahmoudnoble2021@gmail.com",{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Mahmoud Ali Hassan Abdelhamid","specialist of orthopedic surgery","100628776",false,"NCT07466043","Midfoot Osteotomy Versus 8-Plate Epiphysiodesis for Residual Metatarsal Adductus","Midfoot Osteotomy Versus 8-Plate Epiphysiodesis for Residual Metatarsal Adductus in Relapsed Congenital Talipes Equinovarus","Inclusion Criteria:\n\n* Patients are eligible for participation in the study if\n\n  * Age between 5 to 10 years old\n  * Relapsed idiopathic clubfoot (CTEV)\n  * Presence of residual metatarsal adductus\n\nExclusion Criteria:\n\n* Patients are excluded for participation in the study if\n\n  * Teratologic clubfoot (e.g., myelomeningocele).\n  * Children under 4 years of mild severity that could be corrected with conservative treatment, or above 10 years old.\n  * flexible (correctable) deformity of the foot.\n  * Cases recurrent after midtarsal osteotomy\n  * Neuromuscular CTEV, or arthrogryposis","ALL","4 Years","10 Years",{"count":62,"type":63},40,"ESTIMATED","INTERVENTIONAL",[66],"NA","Epiphysiodesis",[69],"Club Foot","NOT_YET_RECRUITING","2026-03-29",{"date":73,"type":74},"2026-04-03","ACTUAL",{"date":76,"type":63},"2026-03-30",{"date":78,"type":63},"2028-02-18",{"name":5,"class":6}]