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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Idiopathic Scoliosis
• Intervention / Treatment: 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

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 Type: Observational
• Enrollment (Anticipated): 16

Contacts and Locations

• Study Contact: Name: Esin Nur Taşdemir, MD; Phone Number: 905353661124; Email: esin.tasdemir@istanbul.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vertebral Body Tethering Group; Vertebral Body Tethering applied to the lumbar region, with or without fusion to the thoracic region	Diagnostic test: Lumbar Spine Magnetic Resonance; Metal artifact reduction sequence (mars), axial t2 sequence; Diagnostic test: 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; Other Names: Cybex; Diagnostic test: Lomber Region Range of motion assessment; To evaluate for lomber region ROM with digital inclinometer; Diagnostic test: Radiograph; spinal radiograph AP/Lateral; Behavioral: SRS 22; SRS-22 Patient Questionnaire
Selective Thoracic Fusion Group; selective thoracic fusion was applied, no intervention was applied to the lumbar region	Diagnostic test: Lumbar Spine Magnetic Resonance; Metal artifact reduction sequence (mars), axial t2 sequence; Diagnostic test: 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; Other Names: Cybex; Diagnostic test: Lomber Region Range of motion assessment; To evaluate for lomber region ROM with digital inclinometer; Diagnostic test: Radiograph; spinal radiograph AP/Lateral; Behavioral: SRS 22; SRS-22 Patient Questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Comparison of VBT and STF group trunk muscle strenght and endurance	Cybex Norm	6 months to 3 years after surgery
Comparison VBT and STF group lomber range of motion	Dual inclinometer	6 months to 3 years after surgery

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Principal Investigator: Esin Nur Taşdemir, MD, Istanbul Medicine Faculty Department of Sports Medicine

Publications and helpful links

General 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.
• 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 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.
• 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):4790. doi: 10.3390/jcm10204790.
• 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):1998-2006. doi: 10.1007/s00586-021-06768-6. Epub 2021 Feb 27.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 9, 2022
• Primary Completion (Anticipated): May 27, 2022
• Study Completion (Anticipated): June 6, 2022

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Scoliosis; Magnetic resonance imaging; Multifidus; Vertebral body tethering; Motion preservation
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: ENTASDEMIR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It is not yet known if there will be a plan to make IPD available.