The Effect of Vertebral Body Tethering on Lumbar Paraspinal Muscle Cross-Section Area in Adolescent Idiopathic Scoliosis

Idiopathic Scoliosis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05347056
• Other study ID #: ENTASDEMIR
• Status: Not yet recruiting
• Start date: May 9, 2022
• Est. completion date: June 6, 2022

Study information

• Verified date: April 2022
• Source: Istanbul University
• Contact: Esin Nur Tasdemir, MD
• Phone: 905353661124
• Email: esin.tasdemir[@]istanbul.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

We aimed to compare the paraspinal muscle cross-section area and functional results of anterior vertebral tethering and selective thoracic fusion surgery.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: June 6, 2022
• Est. primary completion date: May 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 19 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Idiopathic Scoliosis
• Scoliosis

Intervention

Diagnostic Test:
• Lumbar Spine Magnetic Resonance
Metal artifact reduction sequence (mars), axial t2 sequence
• Isokinetic trunk flexion-extension trunk muscle strength and endurance test
To evaluate for trunk muscle strength and endurance angular velocity of 60 and 120°/s
• Lomber Region Range of motion assessment
To evaluate for lomber region ROM with digital inclinometer
• Radiograph
spinal radiograph AP/Lateral

Behavioral:
• SRS 22
SRS-22 Patient Questionnaire

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

References & Publications (4)

Baroncini 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- — View Citation

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. — View Citation

Kim 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). pii: 4790. doi: 1 — View Citation

Pehlivanoglu 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months to 3 years after surgery
Primary	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)	6 months to 3 years after surgery
Secondary	Investigation of Quality of Life in Adolescent Idiopathic Scoliosis	Quality of life Scoliosis Research Society-22 (SRS-22) questionnaire	6 months to 3 years after surgery
Secondary	Comparison of VBT and STF group trunk muscle strenght and endurance	Cybex Norm	6 months to 3 years after surgery
Secondary	Comparison VBT and STF group lomber range of motion	Dual inclinometer	6 months to 3 years after surgery