Unilateral Posterior Wedge ClosingNCT06969339
Unilateral Posterior Wedge Closing Vertebral Column Resection for Treatment of Congenital Kyphoscoliosis
An observational study of Unilateral Posterior Wedge Closing, run by Assiut University.
Trial summary
A retrospective analysis of 12 adolescents undergoing unilateral posterior wedge closing VCR for neglected congenital kyphoscoliosis, assessing surgical outcomes over a mean 2.9-year follow-up. Read more about this study
- Who is it for?
- Ages 10 to 40 years
- Conditions the study is for
- Unilateral Posterior Wedge Closing
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2025to 30 Dec 2026
- Phase
- Observational
- 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 10 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population consisted of adolescents (mean age 15.7 years) with neglected congenital kyphoscoliosis, who had not undergone any prior spinal surgery and had complete preoperative and follow-up imaging data. The sample represents a total coverage of all cases meeting criteria during the study period, reflecting the rarity of congenital kyphoscoliosis requiring surgical intervention in adolescence, The patients who have moderate to severe spinal deformity, with a mean preoperative Cobb angle of 53.2° (kyphoscoliosis involves abnormal curvature in both sagittal and coronal planes, hese cases typically present during adolescence, coinciding with the second growth spurt, which is a known period for progression of congenital spinal deformities
Who may be able to join
- Age >10 years.
- Congenital kyphoscoliosis diagnosis.
- No prior spinal surgery.
- Preoperative CT/MRI and 24-month follow-up data.
Who cannot join
- Idiopathic or neuromuscular scoliosis
- Previous spinal surgery
- Incomplete radiographic or follow-up data
About this study
Official title: Unilateral Posterior Wedge Closing Vertebral Column Resection for Treatment of Adolescent Neglected Congenital Kyphoscoliosis
A retrospective analysis of 12 adolescents undergoing unilateral posterior wedge closing VCR for neglected congenital kyphoscoliosis, assessing surgical outcomes over a mean 2.9-year follow-up.
Read the detailed description
Design: Single-center case series (Assiut University Hospital, 2015-2020).
Intervention: Modified posterior VCR with unilateral convex wedge resection, spinal shortening, and instrumentation.
Key Steps:
Preoperative CT/MRI for anatomical planning.
Posterior-only approach with pedicle screw instrumentation.
Wedge resection focused on convex side, preserving concave continuity.
Bone grafting (cancellous or mesh cage) post-correction.
Follow-up: Radiographic and clinical assessments up to 2 years post-surgery.
- Conditions
- Unilateral Posterior Wedge Closing
- Keywords
- unilateral posterior wedge closing, neglected congenital kyphoscoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with untreated congenital kyphoscoliosis, no prior surgery | adolescent patients with untreated congenital kyphoscoliosis, no prior surgery, and complete imaging/follow-up data. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cobb angle correction
Change in coronal deformity angle (pre-op to post-op and 2-year follow-up).
Measured: Baseline, and 2-year follow-up.
Secondary outcomes (1)
Blood loss
Intraoperative hemorrhage volume.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start30 Aug 2025 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Unilateral Posterior Wedge ClosingStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebram Eissa Moussa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969339
- Sponsor's protocol ID
- Posterior wedge closing
- Status last verified
- May 2025
- First submitted
- 2 May 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Suk SI, Kim JH, Kim WJ, Lee SM, Chung ER, Nah KH. Posterior vertebral column resection for severe spinal deformities. Spine (Phila Pa 1976). 2002 Nov 1;27(21):2374-82. doi: 10.1097/00007632-200211010-00012.
PubMed 12438987Yang JH, Kim HJ, Chang DG, Suh SW, Nam Y, Hong JY. The Efficacy of Single-Stage Correction by Posterior Approach for Neglected Congenital Scoliosis: Comparative Analysis According to the Age of Surgical Intervention. J Clin Med. 2022 Apr 19;11(9):2278. doi: 10.3390/jcm11092278.
PubMed 35566404
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unilateral Posterior Wedge Closing Vertebral Column Resection for Treatment of Adolescent Neglected Congenital Kyphoscoliosis
- ClinicalTrials.gov ID
- NCT06969339
- Acronym / sponsor ID
- Posterior wedge closing
- Conditions
- Unilateral Posterior Wedge Closing
- Keywords
- unilateral posterior wedge closing, neglected congenital kyphoscoliosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Aug 2025 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 13 May 2025 (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.
A retrospective analysis of 12 adolescents undergoing unilateral posterior wedge closing VCR for neglected congenital kyphoscoliosis, assessing surgical outcomes over a mean 2.9-year follow-up.
Detailed description
Design: Single-center case series (Assiut University Hospital, 2015-2020).
Intervention: Modified posterior VCR with unilateral convex wedge resection, spinal shortening, and instrumentation.
Key Steps:
Preoperative CT/MRI for anatomical planning.
Posterior-only approach with pedicle screw instrumentation.
Wedge resection focused on convex side, preserving concave continuity.
Bone grafting (cancellous or mesh cage) post-correction.
Follow-up: Radiographic and clinical assessments up to 2 years post-surgery.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with untreated congenital kyphoscoliosis, no prior surgery | – | –adolescent patients with untreated congenital kyphoscoliosis, no prior surgery, and complete imaging/follow-up data. |
Who may qualify
- Ages
- 10 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population consisted of adolescents (mean age 15.7 years) with neglected congenital kyphoscoliosis, who had not undergone any prior spinal surgery and had complete preoperative and follow-up imaging data. The sample represents a total coverage of all cases meeting criteria during the study period, reflecting the rarity of congenital kyphoscoliosis requiring surgical intervention in adolescence, The patients who have moderate to severe spinal deformity, with a mean preoperative Cobb angle of 53.2° (kyphoscoliosis involves abnormal curvature in both sagittal and coronal planes, hese cases typically present during adolescence, coinciding with the second growth spurt, which is a known period for progression of congenital spinal deformities
Key inclusion criteria (4 listed)
- Age >10 years.
- Congenital kyphoscoliosis diagnosis.
- No prior spinal surgery.
- Preoperative CT/MRI and 24-month follow-up data.
Key exclusion criteria (3 listed)
- Idiopathic or neuromuscular scoliosis
- Previous spinal surgery
- Incomplete radiographic or follow-up data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cobb angle correction
Time frame: Baseline, and 2-year follow-up.
Change in coronal deformity angle (pre-op to post-op and 2-year follow-up).
1 secondary outcome
Blood loss
Time frame: Intraoperative
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 13 May 2025.
- Background: PubMed 12438987Suk SI, Kim JH, Kim WJ, Lee SM, Chung ER, Nah KH. Posterior vertebral column resection for severe spinal deformities. Spine (Phila Pa 1976). 2002 Nov 1;27(21):2374-82. doi: 10.1097/00007632-200211010-00012.
- Background: PubMed 35566404Yang JH, Kim HJ, Chang DG, Suh SW, Nam Y, Hong JY. The Efficacy of Single-Stage Correction by Posterior Approach for Neglected Congenital Scoliosis: Comparative Analysis According to the Age of Surgical Intervention. J Clin Med. 2022 Apr 19;11(9):2278. doi: 10.3390/jcm11092278.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Unilateral Posterior Wedge Closing, run by Assiut University.
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 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cobb angle correction (time frame: Baseline, and 2-year follow-up.). 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 NCT06969339, which also lists 2 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 13 May 2025.