Scoliosis IdiopathicNCT06500195
Hybrid Construct Versus Pedicle Screw-only System for the Treatment Scoliosis
An observational study of Scoliosis Idiopathic and Dysplastic, run by Pomeranian Medical University Szczecin at 1 site in Poland.
Trial summary
The placement of pedicular screws in spinal surgery has become the gold standard for scoliosis treatment. However, the use of sublaminar bands (SBs) on the apex of the curvature in idiopathic scoliosis (AIS) lowers the risk of neurological complications related to incorrect implementation of transpedicular screws into… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Scoliosis Idiopathic, Dysplastic
- What is being tested?
- implantation of the hybrid instrumentation system
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 sitePoland
- Study dates
- 1 Dec 2021to 2 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients who qualified for scoliosis surgery in this center underwent X-ray imaging (AP, lateral, lateral bending view), computed tomography, and magnetic resonance imaging. Patients with a Cobb angle greater than 45 degrees (or 40 degrees in highly progressive cases) were considered eligible for the study. Based on the computed tomography assessment that was performed prior to the surgery, patients were assigned to one of two groups depending on the pedicle type on the apex of the thoracic curvature according to Watanabe pedicle's classification.
Who may be able to join
- idiopathic scoliosis (AIS)
- Lenke type 1
Who cannot join
- AIS other than Lenke type 1 (neurogenic, congenial, or syndromic curvatures)
- abnormalities in the structure of the central nervous system in the MRI image
- advanced chronic respiratory or circulatory failure
- emergency surgery
- reoperation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cobb Angle Comparison of Hybrid Construct Versus Pedicle Screw-only System for the Treatment of Lenke 1 Adolescent Idiopathic Scoliosis
The placement of pedicular screws in spinal surgery has become the gold standard for scoliosis treatment. However, the use of sublaminar bands (SBs) on the apex of the curvature in idiopathic scoliosis (AIS) lowers the risk of neurological complications related to incorrect implementation of transpedicular screws into dysplastic pedicles without a cancellous channel. The latest research does not define a set of anatomical guidelines for applying SBs, nor does it use a dedicated classification system related to the structure of pedicles. The aim of this study was to assess the safety of the method and the correction attained through hypoplastic/aplastic pedicles when applying a hybrid instrumentation system to patients suffering from AIS Lenke type 1. Methods: Twenty patients were involved in a prospective, single-center, non-randomized case series study. The patients were assigned to the group "SCREWS" or "HYBRID" where SBs were used.
Read the detailed description
Adolescent idiopathic scoliosis (AIS) is a three-dimensional deformation of the spine. The goal of the treatment is to achieve a reduction in deformity, restoring proper alignment and the best possible function of the spine. Pedicular screw placement in spinal surgery has become the gold standard for scoliosis reduction techniques in the last 30 years [6]. The screw-only systems are relatively safe, as various authors have proven. However, if implemented incorrectly, the screws increase the risk of damage to nervous or vascular structures and internal organs. The latest research does not define a set of anatomical guidelines for applying SBs, nor does it use a dedicated classification system related to the structure of pedicles. The aim of this study was to assess the safety of the method and the correction attained through hypoplastic/aplastic pedicles when applying a hybrid instrumentation system to patients suffering from AIS Lenke type 1. Methods: Twenty patients were involved in a prospective, single-center, non-randomized case series study. The patients were assigned to the group "SCREWS" or "HYBRID" where SBs were used. The inclusion criteria were this being the patients' first scoliosis operation due to AIS (Lenke type 1) and age under 18 years. The primary measured outcome involved correction efficacy, defined as the Cobb score baseline to endpoint change.
- Conditions
- Scoliosis Idiopathic, Dysplastic
- Being tested
- implantation of the hybrid instrumentation system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implantation of the hybrid instrumentation systemProcedure or surgery
Surgery corrections were performed using the hybrid instrumentation system (screws and bands).
| Study group | Role | What they receive |
|---|---|---|
| SCREWS | The SCREWS group of patients operated on with the use of only transpedicular screws. | |
| HYBRID | The HYBRID group of patients whose corrections were performed using the hybrid instrumentation system (screws and bands). Receives: Procedure: implantation of the hybrid instrumentation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
correction efficacy
defined as the Cobb score baseline to endpoint change (Cobb angle change in the operated spine segment in % at endpoint: X-ray imaging was performed (AP and lateral)
Measured: at the 3rd day after the surgery procedure
Secondary outcomes (1)
length of surgery procedure
duration of the hospitalization measured in minutes
Measured: procedure (from skin incision to skin suture)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start1 Dec 2021
- Primary completion30 Sep 2023
- Study completion2 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis IdiopathicStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500195
- Sponsor's protocol ID
- KB.006.112.2023
- Status last verified
- Jul 2024
- First submitted
- 2 Jul 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: after personal request
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cobb Angle Comparison of Hybrid Construct Versus Pedicle Screw-only System for the Treatment of Lenke 1 Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT06500195
- Acronym / sponsor ID
- KB.006.112.2023
- Conditions
- Scoliosis Idiopathic, Dysplastic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 15 Jul 2024 (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 placement of pedicular screws in spinal surgery has become the gold standard for scoliosis treatment. However, the use of sublaminar bands (SBs) on the apex of the curvature in idiopathic scoliosis (AIS) lowers the risk of neurological complications related to incorrect implementation of transpedicular screws into dysplastic pedicles without a cancellous channel. The latest research does not define a set of anatomical guidelines for applying SBs, nor does it use a dedicated classification system related to the structure of pedicles. The aim of this study was to assess the safety of the method and the correction attained through hypoplastic/aplastic pedicles when applying a hybrid instrumentation system to patients suffering from AIS Lenke type 1. Methods: Twenty patients were involved in a prospective, single-center, non-randomized case series study. The patients were assigned to the group "SCREWS" or "HYBRID" where SBs were used.
Detailed description
Adolescent idiopathic scoliosis (AIS) is a three-dimensional deformation of the spine. The goal of the treatment is to achieve a reduction in deformity, restoring proper alignment and the best possible function of the spine. Pedicular screw placement in spinal surgery has become the gold standard for scoliosis reduction techniques in the last 30 years [6]. The screw-only systems are relatively safe, as various authors have proven. However, if implemented incorrectly, the screws increase the risk of damage to nervous or vascular structures and internal organs. The latest research does not define a set of anatomical guidelines for applying SBs, nor does it use a dedicated classification system related to the structure of pedicles. The aim of this study was to assess the safety of the method and the correction attained through hypoplastic/aplastic pedicles when applying a hybrid instrumentation system to patients suffering from AIS Lenke type 1. Methods: Twenty patients were involved in a prospective, single-center, non-randomized case series study. The patients were assigned to the group "SCREWS" or "HYBRID" where SBs were used. The inclusion criteria were this being the patients' first scoliosis operation due to AIS (Lenke type 1) and age under 18 years. The primary measured outcome involved correction efficacy, defined as the Cobb score baseline to endpoint change.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCREWS | – | –The SCREWS group of patients operated on with the use of only transpedicular screws. |
| HYBRID | – | Procedure: implantation of the hybrid instrumentation systemThe HYBRID group of patients whose corrections were performed using the hybrid instrumentation system (screws and bands). |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients who qualified for scoliosis surgery in this center underwent X-ray imaging (AP, lateral, lateral bending view), computed tomography, and magnetic resonance imaging. Patients with a Cobb angle greater than 45 degrees (or 40 degrees in highly progressive cases) were considered eligible for the study. Based on the computed tomography assessment that was performed prior to the surgery, patients were assigned to one of two groups depending on the pedicle type on the apex of the thoracic curvature according to Watanabe pedicle's classification.
Key inclusion criteria (2 listed)
- idiopathic scoliosis (AIS)
- Lenke type 1
Key exclusion criteria (5 listed)
- AIS other than Lenke type 1 (neurogenic, congenial, or syndromic curvatures)
- abnormalities in the structure of the central nervous system in the MRI image
- advanced chronic respiratory or circulatory failure
- emergency surgery
- reoperation
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 |
|---|---|---|
| implantation of the hybrid instrumentation systemSurgery corrections were performed using the hybrid instrumentation system (screws and bands). | Procedure or surgery | HYBRID |
Primary outcome
correction efficacy
Time frame: at the 3rd day after the surgery procedure
defined as the Cobb score baseline to endpoint change (Cobb angle change in the operated spine segment in % at endpoint: X-ray imaging was performed (AP and lateral)
1 secondary outcome
length of surgery procedure
Time frame: procedure (from skin incision to skin suture)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Individual participant dataSharing planned: Undecided. after personal request
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis Idiopathic and Dysplastic, run by Pomeranian Medical University Szczecin at 1 site in Poland.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 15 Jul 2024. 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
correction efficacy (time frame: at the 3rd day after the surgery procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2024.