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

NCT05347056 | Unknown

• 1 other identifier: ENTASDEMIR
• Study Type: observational
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Idiopathic Scoliosis

Keywords

Scoliosis; Vertebral body tethering; Motion preservation; Multifidus; Magnetic resonance imaging

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Investigation of Quality of Life in Adolescent Idiopathic Scoliosis

  6 months to 3 years after surgery

• Comparison of VBT and STF group trunk muscle strenght and endurance

  6 months to 3 years after surgery

• Comparison VBT and STF group lomber range of motion

  6 months to 3 years after surgery

Study Arms (2)

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; 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

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

Interventions

Lumbar Spine Magnetic Resonance DIAGNOSTIC_TEST

Metal artifact reduction sequence (mars), axial t2 sequence

Selective Thoracic Fusion Group; Vertebral Body Tethering Group

Isokinetic trunk flexion-extension trunk muscle strength and endurance test DIAGNOSTIC_TEST

To evaluate for trunk muscle strength and endurance angular velocity of 60 and 120°/s

Also known as: Cybex

Selective Thoracic Fusion Group; Vertebral Body Tethering Group

Lomber Region Range of motion assessment DIAGNOSTIC_TEST

To evaluate for lomber region ROM with digital inclinometer

Selective Thoracic Fusion Group; Vertebral Body Tethering Group

Radiograph DIAGNOSTIC_TEST

spinal radiograph AP/Lateral

Selective Thoracic Fusion Group; Vertebral Body Tethering Group

SRS 22 BEHAVIORAL

SRS-22 Patient Questionnaire

Selective Thoracic Fusion Group; Vertebral Body Tethering Group

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Related Publications (4)

• 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.

  PMID: 21289549 BACKGROUND

• 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.

  PMID: 33683642 RESULT

• 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.

  PMID: 34682913 RESULT

• 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.

  PMID: 33638722 RESULT

MeSH Terms

Conditions

Scoliosis

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Esin Nur Taşdemir, MD

  Istanbul Medicine Faculty Department of Sports Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esin Nur Taşdemir, MD

CONTACT

905353661124; esin.tasdemir@istanbul.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: April 26, 2022
• Study Start: May 9, 2022
• Primary Completion: May 27, 2022
• Study Completion: June 6, 2022
• Last Updated: April 26, 2022

Record last verified: 2022-04