Early Onset Scoliosis (EOS)APC-EOSNCT07429656
Active Apex Correction (APC) for Early Onset Scoliosis. Early Results of a Pilot Study.
A study testing Active Apex Correction (APC) in people with Early Onset Scoliosis (EOS), run by Assiut University at 1 site in Egypt.
Trial summary
The primary objective of this study is to evaluate the early results of Active Apex Correction (APC) technique for managing early onset scoliosis. Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Early Onset Scoliosis (EOS)
- What is being tested?
- Active Apex Correction (APC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2026to 28 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All patients with progressive early onset scoliosis (congenital, idiopathic, neuromuscular or syndromic).
- Major curve Cobb angle ≥ 40°
- Child below 10 years of age or less than Risser grade 2
- No prior scoliosis surgery
Who cannot join
- Age above 10 years or more than Risser grade 2.
- Operated EOS cases indicated for revision.
- Active infection or systemic illness precluding surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University Hospital
Asyut, Asyut Governorate, 71511
Youssef Sameh Yassin Francis, +201289641423, Yousef.20134510@med.aun.edu.eg
About this study
The primary objective of this study is to evaluate the early results of Active Apex Correction (APC) technique for managing early onset scoliosis.
Read the detailed description
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.
Conservative 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.
Growth-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.
Active 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.
- Conditions
- Early Onset Scoliosis (EOS)
- Being tested
- Active Apex Correction (APC)
- Keywords
- APC, EOS, Active Apex Correction, Early Onset Scoliosis, Scoliosis
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Apex Correction (APC)Procedure or surgery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Early onset scoliosis (EOS) patients | Experimental | Early onset scoliosis (EOS) Any scoliosis starting before the age of 10 years including congenital, neuromuscular, syndromic, and idiopathic types. Receives: Procedure: Active Apex Correction (APC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal Length Correction (T1-T12 and T1-S1) in millimeters.
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.
Measured: At latest follow-up (1 year postoperative)
Secondary outcomes (3)
Percentage of correction of the primary curve (%).
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 (%).
Measured: one year postoperative
Thoracic Kyphosis Angle (Cobb Method) in degrees
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.
Measured: one year postoperative
Number of Participants with Postoperative Complications.
All complications (infection, implant failure, neurological deficit, wound issues) within one year postoperative will be recorded.
Measured: one year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Early Onset Scoliosis (EOS)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model 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. * 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.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youssef Sameh, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429656
- Sponsor's protocol ID
- APC for EOS
- Acronym
- APC-EOS
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25143496Kim 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.
PubMed 36152334Latalski 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.
PubMed 34485105Ahmad 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.
PubMed 32099277Helenius 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.
PubMed 29855249Hatem 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.
PubMed 38687150Andras 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.
PubMed 27927466Wilkinson 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.
PubMed 31393297Agarwal 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.
PubMed 32435564Ahmad 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.
PubMed 32879571
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Apex Correction (APC) for Early Onset Scoliosis. Early Results of a Pilot Study.
- ClinicalTrials.gov ID
- NCT07429656
- Acronym / sponsor ID
- APC-EOS / APC for EOS
- Conditions
- Early Onset Scoliosis (EOS)
- Keywords
- APC, EOS, Active Apex Correction, Early Onset Scoliosis, Scoliosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the early results of Active Apex Correction (APC) technique for managing early onset scoliosis.
Detailed description
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.
Conservative 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.
Growth-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.
Active 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model 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. * 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.
| Arm | Type | Receives |
|---|---|---|
| Early onset scoliosis (EOS) patients | Experimental | Procedure: Active Apex Correction (APC)Early onset scoliosis (EOS) Any scoliosis starting before the age of 10 years including congenital, neuromuscular, syndromic, and idiopathic types. |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- All patients with progressive early onset scoliosis (congenital, idiopathic, neuromuscular or syndromic).
- Major curve Cobb angle ≥ 40°
- Child below 10 years of age or less than Risser grade 2
- No prior scoliosis surgery
Key exclusion criteria (3 listed)
- Age above 10 years or more than Risser grade 2.
- Operated EOS cases indicated for revision.
- Active infection or systemic illness precluding surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Apex Correction (APC)• 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. | Procedure or surgery | Early onset scoliosis (EOS) patients |
Primary outcome
Spinal Length Correction (T1-T12 and T1-S1) in millimeters.
Time frame: At latest follow-up (1 year postoperative)
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.
3 secondary outcomes
Percentage of correction of the primary curve (%).
Time frame: one year postoperative
Thoracic Kyphosis Angle (Cobb Method) in degrees
Time frame: one year postoperative
Number of Participants with Postoperative Complications.
Time frame: one year postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Background: PubMed 25143496Williams 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.
- Background: PubMed 36152334Kim 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.
- Background: PubMed 34485105Latalski 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.
- Background: PubMed 32099277Ahmad 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.
- Background: PubMed 29855249Helenius 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.
- Background: PubMed 38687150Hatem 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.
- Background: PubMed 27927466Andras 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.
- Background: PubMed 31393297Wilkinson 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.
- Background: PubMed 32435564Agarwal 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.
- Background: PubMed 32879571Ahmad 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Apex Correction (APC) in people with Early Onset Scoliosis (EOS), run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Youssef Sameh Yassin Francis (+201289641423, Yousef.20134510@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinal Length Correction (T1-T12 and T1-S1) in millimeters. (time frame: At latest follow-up (1 year postoperative)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07429656, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.