Idiopathic ScoliosisNCT05347056
The Effect of Vertebral Body Tethering on Lumbar Paraspinal Muscle Cross-Section Area in Adolescent Idiopathic Scoliosis
An observational study of Idiopathic Scoliosis, run by Istanbul University.
Trial summary
We aimed to compare the paraspinal muscle cross-section area and functional results of anterior vertebral tethering and selective thoracic fusion surgery. Read more about this study
- Who is it for?
- Ages 12 to 19 years
- Conditions the study is for
- Idiopathic Scoliosis
- What is being tested?
- Lumbar Spine Magnetic Resonance, Isokinetic trunk flexion-extension trunk muscle strength and endurance test and Lomber Region Range of motion assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 9 May 2022to 6 Jun 2022
- 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 12 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: At least 6 months have passed since the surgical procedure, Patients followed in Istanbul Medical Faculty Department of Orthopedics and Traumatology Group 1: VBT applied Group 2: only selective thoracic fusion was applied
Who may be able to join
- Males or females age 12 to 19 years old Diagnosis of idiopathic scoliosis At least 6 months have passed since surgical intervention Spina bifida occulta is permitted
Who cannot join
- Pregnancy Prior spinal or chest surgery MRI abnormalities (including syrinx greater than 4mm, Chiari malformation, or tethered cord) Neuromuscular, thoracogenic, cardiogenic scoliosis, or any other non-idiopathic scoliosis Associated syndrome, including Marfan syndrome or neurofibromatosis
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Vertebral Body Tethering on Lumbar Paraspinal Muscle Cross-Section Area, Lumbar Range of Motion and Trunk Muscle Strength in Adolescent Idiopathic Scoliosis
We aimed to compare the paraspinal muscle cross-section area and functional results of anterior vertebral tethering and selective thoracic fusion surgery.
Read the detailed description
Idiopathic scoliosis is a three-dimensional deformity of the spine. It is defined as the curvature of the spine of 10° or more detected radiologically in the coronal plane. In scoliosis, changes in axial rotation in the transverse plane and physiological curvatures in the sagittal plane (decrease or increase in kyphosis, lordosis) occur.
The incidence of scoliosis is 2-3%, but up to 10% of patients need surgical treatment. Knowing the long-term effects of posterior spinal fusion is currently the gold standard treatment because it gives good results in deformity improvement. However, fusion surgery has disadvantages such as loss of motion in the spine and long-term development of adjacent segment disease and disc degeneration. It has also been suggested that spinal fusion causes iatrogenic damage to the paraspinal muscles (especially the multifidus), which is of great importance in the alignment and movement of the spine due to the posterior approach during surgery.
As a result of damage to the lumbar multifidus muscles and the development of fatty degeneration, problems such as spinal sagittal alignment disorders and chronic low back pain can be seen. In addition, fatty degeneration and atrophy of the paraspinal muscles may lead to the development of adjacent segment disease in the segments under fusion in the long term.
In selective thoracic fusion, by protecting the mobile segments in the lumbar region, the range of motion is preserved and iatrogenic damage of the lumbar paraspinal muscles is prevented. After selective thoracic fusion (STF), some improvement occurs in the deformity in the lumbar region. However, the risk of insufficient improvement and progression of the curve in the unfused lumbar segments, especially in immature patients, should be considered.
Anterior vertebra body tethering is a surgical technique that has been used more frequently in recent years, which is thought to prevent functional complications caused by spinal fusion.With this method, which allows the growth of the spine to continue, there is no need for fusion when treating progressive curvature. Short-term radiological results of this surgical technique have been reported frequently in recent years, but the literature on functional results (spine flexibility, trunk endurance, etc.) is very limited.
In our study, we plan to evaluate the effects of AVT applied to the lumbar region on paraspinal muscle quality, trunk muscle strength and endurance, and trunk joint range of motion by evaluating patients who underwent selective thoracic fusion surgery and patients who underwent thoracic fusion + AVT to the lumbar region.
- Conditions
- Idiopathic Scoliosis
- Being tested
- Lumbar Spine Magnetic Resonance, Isokinetic trunk flexion-extension trunk muscle strength and endurance test, Lomber Region Range of motion assessment, Radiograph, SRS 22
- Keywords
- Scoliosis, Vertebral body tethering, Motion preservation, Multifidus, Magnetic resonance imaging
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Spine Magnetic ResonanceDiagnostic test
Metal artifact reduction sequence (mars), axial t2 sequence
Isokinetic trunk flexion-extension trunk muscle strength and endurance testDiagnostic test
Also called Cybex
To evaluate for trunk muscle strength and endurance angular velocity of 60 and 120°/s
Lomber Region Range of motion assessmentDiagnostic test
To evaluate for lomber region ROM with digital inclinometer
RadiographDiagnostic test
spinal radiograph AP/Lateral
SRS 22Behavioural
SRS-22 Patient Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Vertebral Body Tethering Group | Vertebral Body Tethering applied to the lumbar region, with or without fusion to the thoracic region Receives: Diagnostic Test: Lumbar Spine Magnetic Resonance; Diagnostic Test: Isokinetic trunk flexion-extension trunk muscle strength and endurance test; Diagnostic Test: Lomber Region Range of motion assessment; Diagnostic Test: Radiograph; Behavioral: SRS 22 | |
| Selective Thoracic Fusion Group | selective thoracic fusion was applied, no intervention was applied to the lumbar region Receives: Diagnostic Test: Lumbar Spine Magnetic Resonance; Diagnostic Test: Isokinetic trunk flexion-extension trunk muscle strength and endurance test; Diagnostic Test: Lomber Region Range of motion assessment; Diagnostic Test: Radiograph; Behavioral: SRS 22 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of VBT and STF group paraspinal muscles cross-section area
The bilateral cross-sectional areas (CSA) of the multifidus (MF), erector spinae (ES) and psoas (P) muscles at all disc levels were measured by outlining the fascial boundary of the muscle
Measured: 6 months to 3 years after surgery
Comparison of pre-op and post-op paraspinal muscles cross-section area
The bilateral cross-sectional areas (CSA) of the multifidus (MF), erector spinae (ES) and psoas (P)
Measured: 6 months to 3 years after surgery
Secondary outcomes (3)
Investigation of Quality of Life in Adolescent Idiopathic Scoliosis
Quality of life Scoliosis Research Society-22 (SRS-22) questionnaire
Measured: 6 months to 3 years after surgery
Comparison of VBT and STF group trunk muscle strenght and endurance
Cybex Norm
Measured: 6 months to 3 years after surgery
Comparison VBT and STF group lomber range of motion
Dual inclinometer
Measured: 6 months to 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start9 May 2022 (estimated)
- Primary completion27 May 2022 (estimated)
- Study completion6 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Istanbul 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-control
- Time perspective
- Other
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esin Nur Taşdemir, Istanbul University
- Investigators
- Esin Nur Taşdemir, MD, Principal investigator, Istanbul Medicine Faculty Department of Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347056
- Sponsor's protocol ID
- ENTASDEMIR
- Status last verified
- Apr 2022
- First submitted
- 21 Apr 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Publications
Green DW, Lawhorne TW 3rd, Widmann RF, Kepler CK, Ahern C, Mintz DN, Rawlins BA, Burke SW, Boachie-Adjei O. Long-term magnetic resonance imaging follow-up demonstrates minimal transitional level lumbar disc degeneration after posterior spine fusion for adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2011 Nov 1;36(23):1948-54. doi: 10.1097/BRS.0b013e3181ff1ea9.
PubMed 21289549Pehlivanoglu T, Oltulu I, Erdag Y, Akturk UD, Korkmaz E, Yildirim E, Sarioglu E, Ofluoglu E, Aydogan M. Comparison of clinical and functional outcomes of vertebral body tethering to posterior spinal fusion in patients with adolescent idiopathic scoliosis and evaluation of quality of life: preliminary results. Spine Deform. 2021 Jul;9(4):1175-1182. doi: 10.1007/s43390-021-00323-5. Epub 2021 Mar 8.
PubMed 33683642Kim HJ, Yang JH, Chang DG, Suk SI, Suh SW, Nam Y, Kim SI, Song KS. Long-Term Influence of Paraspinal Muscle Quantity in Adolescent Idiopathic Scoliosis Following Deformity Correction by Posterior Approach. J Clin Med. 2021 Oct 19;10(20):4790. doi: 10.3390/jcm10204790.
PubMed 34682913Baroncini A, Trobisch PD, Berrer A, Kobbe P, Tingart M, Eschweiler J, Da Paz S, Migliorini F. Return to sport and daily life activities after vertebral body tethering for AIS: analysis of the sport activity questionnaire. Eur Spine J. 2021 Jul;30(7):1998-2006. doi: 10.1007/s00586-021-06768-6. Epub 2021 Feb 27.
PubMed 33638722
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vertebral Body Tethering on Lumbar Paraspinal Muscle Cross-Section Area, Lumbar Range of Motion and Trunk Muscle Strength in Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT05347056
- Acronym / sponsor ID
- ENTASDEMIR
- Conditions
- Idiopathic Scoliosis
- Keywords
- Scoliosis, Vertebral body tethering, Motion preservation, Multifidus, Magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 9 May 2022 (estimated)
- Primary completion
- 27 May 2022 (estimated)
- Study completion
- 6 Jun 2022 (estimated)
- First posted
- 26 Apr 2022 (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.
We aimed to compare the paraspinal muscle cross-section area and functional results of anterior vertebral tethering and selective thoracic fusion surgery.
Detailed description
Idiopathic scoliosis is a three-dimensional deformity of the spine. It is defined as the curvature of the spine of 10° or more detected radiologically in the coronal plane. In scoliosis, changes in axial rotation in the transverse plane and physiological curvatures in the sagittal plane (decrease or increase in kyphosis, lordosis) occur.
The incidence of scoliosis is 2-3%, but up to 10% of patients need surgical treatment. Knowing the long-term effects of posterior spinal fusion is currently the gold standard treatment because it gives good results in deformity improvement. However, fusion surgery has disadvantages such as loss of motion in the spine and long-term development of adjacent segment disease and disc degeneration. It has also been suggested that spinal fusion causes iatrogenic damage to the paraspinal muscles (especially the multifidus), which is of great importance in the alignment and movement of the spine due to the posterior approach during surgery.
As a result of damage to the lumbar multifidus muscles and the development of fatty degeneration, problems such as spinal sagittal alignment disorders and chronic low back pain can be seen. In addition, fatty degeneration and atrophy of the paraspinal muscles may lead to the development of adjacent segment disease in the segments under fusion in the long term.
In selective thoracic fusion, by protecting the mobile segments in the lumbar region, the range of motion is preserved and iatrogenic damage of the lumbar paraspinal muscles is prevented. After selective thoracic fusion (STF), some improvement occurs in the deformity in the lumbar region. However, the risk of insufficient improvement and progression of the curve in the unfused lumbar segments, especially in immature patients, should be considered.
Anterior vertebra body tethering is a surgical technique that has been used more frequently in recent years, which is thought to prevent functional complications caused by spinal fusion.With this method, which allows the growth of the spine to continue, there is no need for fusion when treating progressive curvature. Short-term radiological results of this surgical technique have been reported frequently in recent years, but the literature on functional results (spine flexibility, trunk endurance, etc.) is very limited.
In our study, we plan to evaluate the effects of AVT applied to the lumbar region on paraspinal muscle quality, trunk muscle strength and endurance, and trunk joint range of motion by evaluating patients who underwent selective thoracic fusion surgery and patients who underwent thoracic fusion + AVT to the lumbar region.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vertebral Body Tethering Group | – | Diagnostic Test: Lumbar Spine Magnetic Resonance, Diagnostic Test: Isokinetic trunk flexion-extension trunk muscle strength and endurance test, Diagnostic Test: Lomber Region Range of motion assessment, Diagnostic Test: Radiograph, Behavioral: SRS 22Vertebral Body Tethering applied to the lumbar region, with or without fusion to the thoracic region |
| Selective Thoracic Fusion Group | – | Diagnostic Test: Lumbar Spine Magnetic Resonance, Diagnostic Test: Isokinetic trunk flexion-extension trunk muscle strength and endurance test, Diagnostic Test: Lomber Region Range of motion assessment, Diagnostic Test: Radiograph, Behavioral: SRS 22selective thoracic fusion was applied, no intervention was applied to the lumbar region |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- At least 6 months have passed since the surgical procedure, Patients followed in Istanbul Medical Faculty Department of Orthopedics and Traumatology Group 1: VBT applied Group 2: only selective thoracic fusion was applied
Key inclusion criteria (1 listed)
- Males or females age 12 to 19 years old Diagnosis of idiopathic scoliosis At least 6 months have passed since surgical intervention Spina bifida occulta is permitted
Key exclusion criteria (1 listed)
- Pregnancy Prior spinal or chest surgery MRI abnormalities (including syrinx greater than 4mm, Chiari malformation, or tethered cord) Neuromuscular, thoracogenic, cardiogenic scoliosis, or any other non-idiopathic scoliosis Associated syndrome, including Marfan syndrome or neurofibromatosis
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 |
|---|---|---|
| Lumbar Spine Magnetic ResonanceMetal artifact reduction sequence (mars), axial t2 sequence | Diagnostic test | Selective Thoracic Fusion Group, Vertebral Body Tethering Group |
| Isokinetic trunk flexion-extension trunk muscle strength and endurance testAlso: CybexTo evaluate for trunk muscle strength and endurance angular velocity of 60 and 120°/s | Diagnostic test | Selective Thoracic Fusion Group, Vertebral Body Tethering Group |
| Lomber Region Range of motion assessmentTo evaluate for lomber region ROM with digital inclinometer | Diagnostic test | Selective Thoracic Fusion Group, Vertebral Body Tethering Group |
| Radiographspinal radiograph AP/Lateral | Diagnostic test | Selective Thoracic Fusion Group, Vertebral Body Tethering Group |
| SRS 22SRS-22 Patient Questionnaire | Behavioural | Selective Thoracic Fusion Group, Vertebral Body Tethering Group |
Primary outcome
Comparison of VBT and STF group paraspinal muscles cross-section area
Time frame: 6 months to 3 years after surgery
The bilateral cross-sectional areas (CSA) of the multifidus (MF), erector spinae (ES) and psoas (P) muscles at all disc levels were measured by outlining the fascial boundary of the muscle
Comparison of pre-op and post-op paraspinal muscles cross-section area
Time frame: 6 months to 3 years after surgery
The bilateral cross-sectional areas (CSA) of the multifidus (MF), erector spinae (ES) and psoas (P)
3 secondary outcomes
Investigation of Quality of Life in Adolescent Idiopathic Scoliosis
Time frame: 6 months to 3 years after surgery
Comparison of VBT and STF group trunk muscle strenght and endurance
Time frame: 6 months to 3 years after surgery
Comparison VBT and STF group lomber range of motion
Time frame: 6 months to 3 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Background: PubMed 21289549Green DW, Lawhorne TW 3rd, Widmann RF, Kepler CK, Ahern C, Mintz DN, Rawlins BA, Burke SW, Boachie-Adjei O. Long-term magnetic resonance imaging follow-up demonstrates minimal transitional level lumbar disc degeneration after posterior spine fusion for adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2011 Nov 1;36(23):1948-54. doi: 10.1097/BRS.0b013e3181ff1ea9.
- Results publication: PubMed 33683642Pehlivanoglu T, Oltulu I, Erdag Y, Akturk UD, Korkmaz E, Yildirim E, Sarioglu E, Ofluoglu E, Aydogan M. Comparison of clinical and functional outcomes of vertebral body tethering to posterior spinal fusion in patients with adolescent idiopathic scoliosis and evaluation of quality of life: preliminary results. Spine Deform. 2021 Jul;9(4):1175-1182. doi: 10.1007/s43390-021-00323-5. Epub 2021 Mar 8.
- Results publication: PubMed 34682913Kim HJ, Yang JH, Chang DG, Suk SI, Suh SW, Nam Y, Kim SI, Song KS. Long-Term Influence of Paraspinal Muscle Quantity in Adolescent Idiopathic Scoliosis Following Deformity Correction by Posterior Approach. J Clin Med. 2021 Oct 19;10(20):4790. doi: 10.3390/jcm10204790.
- Results publication: PubMed 33638722Baroncini A, Trobisch PD, Berrer A, Kobbe P, Tingart M, Eschweiler J, Da Paz S, Migliorini F. Return to sport and daily life activities after vertebral body tethering for AIS: analysis of the sport activity questionnaire. Eur Spine J. 2021 Jul;30(7):1998-2006. doi: 10.1007/s00586-021-06768-6. Epub 2021 Feb 27.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
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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.
Esin Nur Taşdemir, MD principal investigator
Istanbul Medicine Faculty Department of Sports Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Scoliosis, run by Istanbul 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esin Nur Taşdemir, MD (905353661124, esin.tasdemir@istanbul.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of VBT and STF group paraspinal muscles cross-section area (time frame: 6 months to 3 years after surgery). The study lists 2 primary outcomes in all. 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 NCT05347056, which also lists 4 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 26 Apr 2022.