Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 8:53 AM
Study NCT ID:
NCT07429656
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-25
First Post:
2026-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Active Apex Correction (APC) for Early Onset Scoliosis. Early Results of a Pilot Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012600', 'term': 'Scoliosis'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '* Active Apex Correction (APC) begins with the identification of the curve apex and the selection of upper and lower "foundation" vertebrae, where pedicle screws are placed on the convex side only, above and below the most wedged vertebrae. No screws are inserted on the concave side, avoiding the need for osteotomies at the apex. The rods are then connected to both upper and lower foundation constructs, contoured to maintain appropriate sagittal alignment.\n* To permit continued spinal growth, controlled sliding is achieved either using domino connectors or specialized sliding screws. The convex-side screws are compressed before final tightening. This compression applies targeted pressure to the vertebral body, promoting gradual vertebral remodulation (reverse modulation) and reduction of apical wedging over time. Rod sliding through domino connectors allows continued longitudinal growth, eliminating the need for repeated lengthening surgeries typical of traditional growing rods.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-02-13', 'studyFirstSubmitQcDate': '2026-02-20', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spinal Length Correction (T1-T12 and T1-S1) in millimeters.', 'timeFrame': 'At latest follow-up (1 year postoperative)', 'description': 'Spinal length will be assessed on standing full-spine radiographs at the latest postoperative follow-up. Measurements will include the distance from T1 to T12 and from T1 to S1 in millimeters.'}], 'secondaryOutcomes': [{'measure': 'Percentage of correction of the primary curve (%).', 'timeFrame': 'one year postoperative', 'description': 'The Cobb angle of the primary scoliotic curve will be measured on preoperative and latest postoperative standing radiographs. The correction will be calculated in Percentage (%).'}, {'measure': 'Thoracic Kyphosis Angle (Cobb Method) in degrees', 'timeFrame': 'one year postoperative', 'description': 'Thoracic kyphosis will be measured on lateral standing radiographs between T1 and T12 using the Cobb angle method. The angle will be recorded in degrees (°) at the latest postoperative follow-up.'}, {'measure': 'Number of Participants with Postoperative Complications.', 'timeFrame': 'one year postoperative', 'description': 'All complications (infection, implant failure, neurological deficit, wound issues) within one year postoperative will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['APC', 'EOS', 'Active Apex Correction', 'Early Onset Scoliosis', 'Scoliosis'], 'conditions': ['Early Onset Scoliosis (EOS)']}, 'referencesModule': {'references': [{'pmid': '25143496', 'type': 'BACKGROUND', 'citation': 'Williams BA, Matsumoto H, McCalla DJ, Akbarnia BA, Blakemore LC, Betz RR, Flynn JM, Johnston CE, McCarthy RE, Roye DP Jr, Skaggs DL, Smith JT, Snyder BD, Sponseller PD, Sturm PF, Thompson GH, Yazici M, Vitale MG. Development and initial validation of the Classification of Early-Onset Scoliosis (C-EOS). J Bone Joint Surg Am. 2014 Aug 20;96(16):1359-67. doi: 10.2106/JBJS.M.00253.'}, {'pmid': '36152334', 'type': 'BACKGROUND', 'citation': 'Kim G, Sammak SE, Michalopoulos GD, Mualem W, Pinter ZW, Freedman BA, Bydon M. Comparison of surgical interventions for the treatment of early-onset scoliosis: a systematic review and meta-analysis. J Neurosurg Pediatr. 2022 Sep 23;31(4):342-357. doi: 10.3171/2022.8.PEDS22156. Print 2022 Sep 1.'}, {'pmid': '34485105', 'type': 'BACKGROUND', 'citation': 'Latalski M, Fatyga M, Sowa I, Wojciak M, Starobrat G, Danielewicz A. Complications in growth-friendly spinal surgeries for early-onset scoliosis: Literature review. World J Orthop. 2021 Aug 18;12(8):584-603. doi: 10.5312/wjo.v12.i8.584. eCollection 2021 Aug 18.'}, {'pmid': '32099277', 'type': 'BACKGROUND', 'citation': 'Ahmad AA. Early onset scoliosis and current treatment methods. J Clin Orthop Trauma. 2020 Mar-Apr;11(2):184-190. doi: 10.1016/j.jcot.2019.12.011. Epub 2019 Dec 24.'}, {'pmid': '29855249', 'type': 'BACKGROUND', 'citation': 'Helenius IJ, Oksanen HM, McClung A, Pawelek JB, Yazici M, Sponseller PD, Emans JB, Sanchez Perez-Grueso FJ, Thompson GH, Johnston C, Shah SA, Akbarnia BA. Outcomes of growing rod surgery for severe compared with moderate early-onset scoliosis: a matched comparative study. Bone Joint J. 2018 Jun 1;100-B(6):772-779. doi: 10.1302/0301-620X.100B6.BJJ-2017-1490.R1.'}, {'pmid': '38687150', 'type': 'BACKGROUND', 'citation': 'Hatem A, Elmorshidy EM, Elkot A, Hassan KM, El-Sharkawi M. Autofusion in growing rod surgery for early onset scoliosis; what do we know so far? SICOT J. 2024;10:15. doi: 10.1051/sicotj/2024011. Epub 2024 Apr 30.'}, {'pmid': '27927466', 'type': 'BACKGROUND', 'citation': 'Andras LM, Joiner ER, McCarthy RE, McCullough L, Luhmann SJ, Sponseller PD, Emans JB, Barrett KK, Skaggs DL; Growing Spine Study Group. Growing Rods Versus Shilla Growth Guidance: Better Cobb Angle Correction and T1-S1 Length Increase But More Surgeries. Spine Deform. 2015 May;3(3):246-252. doi: 10.1016/j.jspd.2014.11.005. Epub 2015 Apr 23.'}, {'pmid': '31393297', 'type': 'BACKGROUND', 'citation': 'Wilkinson JT, Songy CE, Bumpass DB, McCullough FL, McCarthy RE. Curve Modulation and Apex Migration Using Shilla Growth Guidance Rods for Early-onset Scoliosis at 5-Year Follow-up. J Pediatr Orthop. 2019 Sep;39(8):400-405. doi: 10.1097/BPO.0000000000000983.'}, {'pmid': '32435564', 'type': 'BACKGROUND', 'citation': 'Agarwal A, Aker L, Ahmad AA. Active Apex Correction With Guided Growth Technique for Controlling Spinal Deformity in Growing Children: A Modified SHILLA Technique. Global Spine J. 2020 Jun;10(4):438-442. doi: 10.1177/2192568219859836. Epub 2019 Jun 23.'}, {'pmid': '32879571', 'type': 'BACKGROUND', 'citation': 'Ahmad AA, Agarwal A. Active Apex Correction: An overview of the modified SHILLA technique and its clinical efficacy. J Clin Orthop Trauma. 2020 Sep-Oct;11(5):848-852. doi: 10.1016/j.jcot.2020.07.013. Epub 2020 Jul 23.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the early results of Active Apex Correction (APC) technique for managing early onset scoliosis.', 'detailedDescription': 'Early onset scoliosis (EOS) presents a significant clinical challenge due to progressive spinal deformity during critical periods of spinal and thoracic growth. Inadequate management may result in thoracic insufficiency, impaired pulmonary development, and long-term cardiopulmonary morbidity. Achieving deformity control while preserving spinal growth remains the primary treatment goal.\n\nConservative strategies such as bracing and serial casting may delay progression but are often insufficient, necessitating surgical intervention.Early definitive spinal fusion arrests spinal growth and causes truncal shortening.\n\nGrowth-friendly, non-fusion techniques preserve spinal growth while controlling deformity. Traditional growing rods (TGR) require repeated surgical lengthening, resulting in high complication risks including infection, implant failure, and unplanned reoperations. Repeated distractions may lead to unintended spinal autofusion, compromising growth potential. Magnetically controlled growing rods reduce repeated surgeries but remain costly with mechanical failure risks. The Shilla system allows spinal growth but faces loss of correction and implant failure.\n\nActive Apex Correction (APC) is a relatively novel growth-friendly surgical technique, first innovated approximately 16 years ago, gaining increasing international interest recently. APC, a Shilla modification, addresses limitations of existing growth-preserving strategies. APC employs a single surgical procedure with unilateral convex-side compression at the curve apex, allowing guided spinal growth while avoiding concave-side instrumentation, osteotomies, and repeated lengthening procedures. This approach may reduce operative time, implant density, infection risk, and treatment cost. However, despite theoretical advantages, clinical data on APC remain limited. Therefore, evaluating radiographic correction, growth preservation, and clinical outcomes with APC is necessary to define its role in managing EOS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with progressive early onset scoliosis (congenital, idiopathic, neuromuscular or syndromic).\n* Major curve Cobb angle ≥ 40°\n* Child below 10 years of age or less than Risser grade 2\n* No prior scoliosis surgery\n\nExclusion Criteria:\n\n* Age above 10 years or more than Risser grade 2.\n* Operated EOS cases indicated for revision.\n* Active infection or systemic illness precluding surgery.'}, 'identificationModule': {'nctId': 'NCT07429656', 'acronym': 'APC-EOS', 'briefTitle': 'Active Apex Correction (APC) for Early Onset Scoliosis. Early Results of a Pilot Study.', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Active Apex Correction (APC) for Early Onset Scoliosis. Early Results of a Pilot Study.', 'orgStudyIdInfo': {'id': 'APC for EOS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early onset scoliosis (EOS) patients', 'description': 'Early onset scoliosis (EOS) Any scoliosis starting before the age of 10 years including congenital, neuromuscular, syndromic, and idiopathic types.', 'interventionNames': ['Procedure: Active Apex Correction (APC)']}], 'interventions': [{'name': 'Active Apex Correction (APC)', 'type': 'PROCEDURE', 'description': '• Active Apex Correction (APC) begins with the identification of the curve apex and the selection of upper and lower "foundation" vertebrae, where pedicle screws are placed on the convex side only, above and below the most wedged vertebrae. No screws are inserted on the concave side, avoiding the need for osteotomies at the apex. The rods are then connected to both upper and lower foundation constructs, contoured to maintain appropriate sagittal alignment.', 'armGroupLabels': ['Early onset scoliosis (EOS) patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71511', 'city': 'Asyut', 'state': 'Asyut Governorate', 'country': 'Egypt', 'contacts': [{'name': 'Youssef Sameh Yassin Francis', 'role': 'CONTACT', 'email': 'Yousef.20134510@med.aun.edu.eg', 'phone': '+201289641423'}], 'facility': 'Assiut University Hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Youssef Sameh Yassin Francis', 'role': 'CONTACT', 'email': 'Yousef.20134510@med.aun.edu.eg', 'phone': '+201289641423'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assisstant Lecturer', 'investigatorFullName': 'Youssef Sameh', 'investigatorAffiliation': 'Assiut University'}}}}