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

Primary Purpose

Adolescent Idiopathic Scoliosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Posterior spinal fusion with pedicle screws
Anterior vertebral body tethering
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Idiopathic Scoliosis focused on measuring Scoliosis, Spinal Diseases

Eligibility Criteria

10 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • AIS Lenke type I A,B or C
  • Age 10-16 years
  • Skeletally immature (Sanders classification between 2 and 5)
  • 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 (Sanders >5)
  • Patients who have evidence of neurological disorders
  • Patients who have undergone intrathoracic surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Posterior spinal fusion with pedicle screws

    Anterior vertebral body tethering

    Arm Description

    Outcomes

    Primary Outcome Measures

    Cobb angle correction of instrumented curve at 2 year follow up
    Major Curve Cobb Angle (Cobb, 1948)
    Total score of SRS-24 questionnaire at 2 year follow up
    SRS-24 outcome questionnaire. Total score between 1 to 5

    Secondary Outcome Measures

    Complication rate
    deep surgical site infection, neurologic deficit
    Revision rate
    Any re-intervention
    Pulmonary function at 2-year follow-up
    FVC (% predicted)
    Spinal mobility at 2-year follow-up
    Trunk side bending (finger tip to knee joint, cm), forward bending (finger tip to floor distance, cm)

    Full Information

    First Posted
    September 24, 2020
    Last Updated
    October 15, 2020
    Sponsor
    Turku University Hospital
    Collaborators
    Helsinki University Central Hospital, Oxford University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04590807
    Brief Title
    Posterior Spinal Fusion With Pedicle Screws vs. Anterior Vertebral Body Tethering in Adolescent Idiopathic Scoliosis
    Official Title
    Posterior Spinal Fusion With Pedicle Screws vs. Anterior Vertebral Body Tethering in Adolescent Idiopathic Scoliosis (AIS): an International Multicenter Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2021 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Turku University Hospital
    Collaborators
    Helsinki University Central Hospital, Oxford University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    Detailed Description
    Background- Adolescent idiopathic scoliosis is the most common indication for major surgery in adolescents (between 10 and 18 years of age). 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. The aim of spinal fusion is to prevent further curve progression but also to correct the spinal deformity and achieve a cosmetically pleasing result by reducing the rib hump and balancing the trunk and shoulders. While this procedure has been very successful, it has inherent downsides such as the decreased range of motion and loss of spinal mobility in addition to the inhibition of growth along the instrumentation. To prevent distal adding on (continued curve below instrumentation) due to continued anterior spinal growth, it is often necessary to fuse the spine into stable vertebra resulting into even longer spinal fusion levels in the lumbar spine (Sponseller et al. JPO 2016; Oksanen et al. SJS 2018). Spinal fusion increases loading of the remaining mobile segments (Parsch et al. JBJS Br 2001). In a five-year follow-up study spinal fusion resulted into better health-related quality of life (HRQoL) as compared with untreated AIS (Helenius et al. JBJS 2019). However, the function domain of HRQoL was significantly less after spinal fusion as compared with healthy controls. In contrast, 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. There is currently a paucity of literature on the effectiveness of vertebral body tethering (VBT) with only retrospective case series published and reported in conference proceedings, and a comparative study is completely lacking. Initial complication rates with the implants for tethering have also sparked caution amongst surgeons and payers whether or not to adopt this technique despite its theoretical advantages. Thus, a high-quality comparative prospective study is missing to demonstrate the effectiveness and safety of vertebral body tethering compared to posterior spinal fusion. If this can be shown in a well-designed study, it is likely to result in a paradigm shift in the treatment of AIS similar to the impact earlier technical novelties and achievements had. Randomised controlled trials are rare in paediatric orthopaedic research. It would be unprecedented that evidence from an RCT is driving a change in practice in scoliosis surgery. Aims and hypothesis- To compare posterior fusion to VBT for the treatment of AIS. Aim is 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- The inclusion criteria would aim to restrict the study to paediatric patients with AIS and the following criteria: Lenke type I A,B or C, age 10-16 years, skeletally immature (Sanders classification between 2 and 5), 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 (Sanders >5), 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 Interventions: AVBT from end to end vertebra. PSF levels using the Lenke criteria. 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. Time schedule and budget- The study will be started on beginning of 2021. Patient enrollment is expected to last to the end of 2023. There will be no extra costs as all information gathered will be part of normal surgical treatment of AIS. A part-time research nurse has been hired to take care of data collection into the database. References: Sponseller PD, Jain A, Newton PO et al. Posterior Spinal Fusion With Pedicle Screws in Patients With Idiopathic Scoliosis and Open Triradiate Cartilage: Does Deformity Progression Occur? J Pediatr Orthop 2016; 36:695-700. Oksanen H, Lastikka M, Helenius L, et al. Posterior Spinal Fusion Extended to Stable Vertebra Provides Similar Outcome in Juvenile Idiopathic Scoliosis Patients Compared with Adolescents with Fusion to the Touched Vertebra. Scand J Surg 2019 Mar; 108(1):83-89. Parsch et al. JBJS Br 2001 Helenius L, Diabakerli E, Grauers A, et al. Back Pain and Quality of Life after Surgical Treatment for Adolescent Idiopathic Scoliosis

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adolescent Idiopathic Scoliosis
    Keywords
    Scoliosis, Spinal Diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Posterior spinal fusion with pedicle screws
    Arm Type
    Active Comparator
    Arm Title
    Anterior vertebral body tethering
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    Posterior spinal fusion with pedicle screws
    Intervention Description
    Implanting pedicle screws and rods
    Intervention Type
    Device
    Intervention Name(s)
    Anterior vertebral body tethering
    Intervention Description
    Vertebral screws and cable
    Primary Outcome Measure Information:
    Title
    Cobb angle correction of instrumented curve at 2 year follow up
    Description
    Major Curve Cobb Angle (Cobb, 1948)
    Time Frame
    2 years follow-up
    Title
    Total score of SRS-24 questionnaire at 2 year follow up
    Description
    SRS-24 outcome questionnaire. Total score between 1 to 5
    Time Frame
    2 years follow-up
    Secondary Outcome Measure Information:
    Title
    Complication rate
    Description
    deep surgical site infection, neurologic deficit
    Time Frame
    2 years follow-up
    Title
    Revision rate
    Description
    Any re-intervention
    Time Frame
    2 years follow-up
    Title
    Pulmonary function at 2-year follow-up
    Description
    FVC (% predicted)
    Time Frame
    2 years follow-up
    Title
    Spinal mobility at 2-year follow-up
    Description
    Trunk side bending (finger tip to knee joint, cm), forward bending (finger tip to floor distance, cm)
    Time Frame
    2 years follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: AIS Lenke type I A,B or C Age 10-16 years Skeletally immature (Sanders classification between 2 and 5) 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 (Sanders >5) Patients who have evidence of neurological disorders Patients who have undergone intrathoracic surgery
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ilkka J Helenius, MD, Prof
    Phone
    +358443380034
    Email
    ilkka.helenius@tyks.fi
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hanna M Oksanen, RN
    Phone
    +358407599395
    Email
    hanna.oksanen@tyks.fi

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30277999
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    32043058
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    32379117
    Citation
    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.
    Results Reference
    result

    Learn more about this trial

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

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