Posterior Spinal Fusion With Pedicle Screws vs. Anterior Vertebral Body Tethering in Adolescent Idiopathic Scoliosis

NCT04590807 | Unknown

• 1 other identifier: ETMK 15/1801/2020
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background- Adolescent idiopathic scoliosis is the most common indication for major surgery in adolescents. The current standard of care for adolescent idiopathic scoliosis (AIS) with a curve magnitude of over 40-50˚ in skeletally immature patients, is posterior spinal fusion with pedicle screws. Vertebral body tethering using screws connected by a tether in the anterior vertebral body, has the potential to initially correct the still flexible deformity, but most importantly modulate growth and ultimately result in scoliosis correction with a mobile spine. A high-quality comparative prospective study is missing to demonstrate the effectiveness and safety of vertebral body tethering compared to posterior spinal fusion. Study Design- An international, randomized clinical trial on posterior spinal fusion with pedicle screws vs. Anterior vertebral body tethering in Adolescent Idiopathic Scoliosis (AIS) Aims- To demonstrate non-inferiority of VBT compared to posterior fusion in terms of main curve correction of AIS at the 2 year follow up, to demonstrate comparable outcomes for SRS-22/24 at the 2 year follow up. Aim is also to compare complication and revision rates and to compare spinal mobility including flexion and side bending between the study groups. Inclusion criteria- Lenke type I A,B or C, age 10-16 years, skeletally immature, Cobb angle 40-60˚, 50% flexibility on supine bending films, selective thoracic fusion feasible Exclusion criteria- Any other than idiopathic scoliosis, less than 50% curve flexibility, skeletal maturity, patients who have evidence of neurological disorders, patients who have undergone intrathoracic surgery Outcome parametres- Cobb angle correction of instrumented curve at 2 year follow up, total score of SRS questionnaire at 2 year follow up; secondary outcomes: Complication and revision rates, pulmonary function at 2-year follow-up, spinal mobility at 2-year follow-up Ethical aspects- Each institution in each country is responsible for obtaining either institutional review board approval or approval from a national ethics committee as appropriate. An informed consent will be obtained from all children and their parents.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Scoliosis; Spinal Diseases

Outcome Measures

Primary Outcomes (2)

• Cobb angle correction of instrumented curve at 2 year follow up

  Major Curve Cobb Angle (Cobb, 1948)

  2 years follow-up

• Total score of SRS-24 questionnaire at 2 year follow up

  SRS-24 outcome questionnaire. Total score between 1 to 5

  2 years follow-up

Secondary Outcomes (4)

• Complication rate

  2 years follow-up

• Revision rate

  2 years follow-up

• Pulmonary function at 2-year follow-up

  2 years follow-up

• Spinal mobility at 2-year follow-up

  2 years follow-up

Study Arms (2)

Posterior spinal fusion with pedicle screws

ACTIVE COMPARATOR

Device: Posterior spinal fusion with pedicle screws

Anterior vertebral body tethering

ACTIVE COMPARATOR

Device: Anterior vertebral body tethering

Interventions

Posterior spinal fusion with pedicle screws DEVICE

Implanting pedicle screws and rods

Posterior spinal fusion with pedicle screws

Anterior vertebral body tethering DEVICE

Vertebral screws and cable

Anterior vertebral body tethering

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• AIS Lenke type I A,B or C
• Age 10-16 years
• Skeletally immature (Sanders classification between 2 and 5)
• Cobb angle 40-60˚
• % flexibility on supine bending films.
• Selective thoracic fusion feasible

You may not qualify if:

• Any other than idiopathic scoliosis
• Less than 50% curve flexibility
• Skeletal maturity (Sanders \>5)
• Patients who have evidence of neurological disorders
• Patients who have undergone intrathoracic surgery

Sponsors & Collaborators

• Turku University Hospital: lead
• Helsinki University Central Hospital: collaborator
• Oxford University Hospitals NHS Trust: collaborator

Related Publications (3)

• Newton PO, Kluck DG, Saito W, Yaszay B, Bartley CE, Bastrom TP. Anterior Spinal Growth Tethering for Skeletally Immature Patients with Scoliosis: A Retrospective Look Two to Four Years Postoperatively. J Bone Joint Surg Am. 2018 Oct 3;100(19):1691-1697. doi: 10.2106/JBJS.18.00287.

  PMID: 30277999 RESULT

• Wong HK, Ruiz JNM, Newton PO, Gabriel Liu KP. Non-Fusion Surgical Correction of Thoracic Idiopathic Scoliosis Using a Novel, Braided Vertebral Body Tethering Device: Minimum Follow-up of 4 Years. JB JS Open Access. 2019 Dec 12;4(4):e0026. doi: 10.2106/JBJS.OA.19.00026. eCollection 2019 Oct-Dec.

  PMID: 32043058 RESULT

• Newton PO, Bartley CE, Bastrom TP, Kluck DG, Saito W, Yaszay B. Anterior Spinal Growth Modulation in Skeletally Immature Patients with Idiopathic Scoliosis: A Comparison with Posterior Spinal Fusion at 2 to 5 Years Postoperatively. J Bone Joint Surg Am. 2020 May 6;102(9):769-777. doi: 10.2106/JBJS.19.01176.

  PMID: 32379117 RESULT

MeSH Terms

Conditions

Scoliosis; Spinal Diseases

Interventions

Pedicle Screws

Condition Hierarchy (Ancestors)

Spinal Curvatures; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Bone Screws; Internal Fixators; Prostheses and Implants; Equipment and Supplies; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Surgical Fixation Devices

Central Study Contacts

Ilkka J Helenius, MD, Prof

CONTACT

+358443380034; ilkka.helenius@tyks.fi

Hanna M Oksanen, RN

CONTACT

+358407599395; hanna.oksanen@tyks.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: October 19, 2020
• Study Start: January 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share