Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:53 AM
Study NCT ID:
NCT07449650
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-04
First Post:
2026-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Calcaneal Lengthening Osteotomy With Locking Wedge Plate Versus Synthetic PEEK Cage Interposition for Symptomatic Flexible Pes Planovalgus Foot Deformity in Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005413', 'term': 'Flatfoot'}], 'ancestors': [{'id': 'D000070558', 'term': 'Talipes'}, {'id': 'D005531', 'term': 'Foot Deformities, Acquired'}, {'id': 'D005530', 'term': 'Foot Deformities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D005532', 'term': 'Foot Deformities, Congenital'}, {'id': 'D038061', 'term': 'Lower Extremity Deformities, Congenital'}, {'id': 'D017880', 'term': 'Limb Deformities, Congenital'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-02-27', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Foot and ankle ability measure visual analogue scale radiological', 'timeFrame': '1 year', 'description': 'clinical and radiological'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Flexible Flatfoot or Pes Planus']}, 'descriptionModule': {'briefSummary': 'The goal of this interventional study is to compare clinical outcome, radiological parameters, complication rates and time to recovery of calcaneal lengthening osteotomy with locking wedge plate versus PEEK cage interposition in management of symptomatic flexible pes planovalgus foot deformity in adolescents'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patients with symptomatic flexible pes planovalgus indicated for surgical correction\n2. age: from 10 years to 17 years\n3. sex: males and females\n4. failure of conservative management\n\nExclusion Criteria:\n\n1. previous foot surgery\n2. patients with neuromuscular disorders\n3. patients with rigid pes Plano valgus\n4. patients with sever comorbidities'}, 'identificationModule': {'nctId': 'NCT07449650', 'briefTitle': 'Calcaneal Lengthening Osteotomy With Locking Wedge Plate Versus Synthetic PEEK Cage Interposition for Symptomatic Flexible Pes Planovalgus Foot Deformity in Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Calcaneal Lengthening Osteotomy With Locking Wedge Plate Versus Synthetic PEEK Cage Interposition for Symptomatic Flexible Pes Planovalgus Foot Deformity in Adolescents', 'orgStudyIdInfo': {'id': 'Soh-Med-26-1-4MD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'calcaneal lengthening osteotomy with locking wedge plate fixation', 'description': 'one group will undergo calcaneal lengthening osteotomy to lengthen lateral columan using locking wedge plate fixation to maintain lengthening', 'interventionNames': ['Procedure: calcaneal lengthening osteotomy', 'Procedure: calcaneal lengthening osteotomy with locking wedge plate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'calcaneal lengthening osteotomy with PEEK cage interposition', 'description': 'second group will undergo calcaneal lengthening osteotomy to lengthen lateral columan using PEEK cage interposition to maintain lengthening', 'interventionNames': ['Procedure: calcaneal lengthening osteotomy', 'Procedure: calcaneal lengthening osteotomy with synthetic PEEK cage interposition']}], 'interventions': [{'name': 'calcaneal lengthening osteotomy', 'type': 'PROCEDURE', 'description': 'calcaneal lengthening osteotomy is a surgical procedure to correct symptomatic flexible pes planovalgus foot deformity in adolescents', 'armGroupLabels': ['calcaneal lengthening osteotomy with PEEK cage interposition', 'calcaneal lengthening osteotomy with locking wedge plate fixation']}, {'name': 'calcaneal lengthening osteotomy with locking wedge plate', 'type': 'PROCEDURE', 'description': 'one group will undergo calcaneal lengthening osteotomy with locking wedge plate fixation to maintain lengthening', 'armGroupLabels': ['calcaneal lengthening osteotomy with locking wedge plate fixation']}, {'name': 'calcaneal lengthening osteotomy with synthetic PEEK cage interposition', 'type': 'PROCEDURE', 'description': 'second group will undergo calcaneal lengthening osteotomy with PEEK cage interposition to maintain lengthening', 'armGroupLabels': ['calcaneal lengthening osteotomy with PEEK cage interposition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '82716', 'city': 'Sohag', 'country': 'Egypt', 'facility': 'Sohag Faculty of Medicine', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Mohamed Elsayed Osman, specialist', 'role': 'CONTACT', 'email': 'mohamed_elsayed_post@med.sohag.edu.eg', 'phone': '020-01006254523'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mohamed Elsayed Othman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'orthopaedic specialist', 'investigatorFullName': 'Mohamed Elsayed Othman', 'investigatorAffiliation': 'Sohag University'}}}}