NCT01792609

Brief Summary

Objectives Primary objective: Determine if there is a clinically significant difference in percent Cobb curve correction in a low- vs. high-implant density cohort through a prospective randomized controlled trial. Design and Outcomes Randomized clinical trial of equivalence to test the efficacy and safety of low vs. high implant density instrumentation for spine deformity surgery in AIS patients with Lenke IA curve patterns. Interventions and Duration Intervention: low-implant density group or high-implant density group. Duration: 2 years. Sample Size and Population Target population: 10 to 17 years old with AIS who will undergo instrumented spinal fusion. Sample size needed (power = 90%) is 174 subjects with 87 in each group.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
2 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2013

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

April 18, 2013

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

6.1 years

First QC Date

January 22, 2013

Last Update Submit

August 2, 2022

Conditions

ScoliosisAdolescent Idiopathic Scoliosis

Keywords

ScoliosisCobb AngleScrew DensityOutcomes Measures

Outcome Measures

Primary Outcomes (1)

  • Change in Cobb Angle

    Radiographic, surgical, and patient-reported data will be gathered and analyzed to observe changes between time points. All radiographs will be taken with 3D analysis capability, either with a calibration belt using standard radiograph techniques or with an EOS imaging system. This will allow for additional detailed correction measures, such as change in spinal rotation (orientation of the planes of maximum curvature) and detailed coronal, sagittal and transverse plane measures. Bending films will be taken according to institutional protocol. The SRS-30, SAQ, and EQ5D will be collected at all clinical visits. Study questions will be aligned as much as possible with other prospective scoliosis protocols so as to minimize patient and surgeon response burden. The study protocol requires no additional visits or radiographs beyond standard of care.

    pre-surgery ranging 1 year to 1 month and peri surgery at about 3-months, 1-year, and 2-year postoperative

Secondary Outcomes (3)

  • Blood Loss

    During surgery, 1 time occurence

  • Operative Time

    1 time measurement, occurs at surgery

  • 3D parameter correction

    collected during surgical procedure

Study Arms (2)

Maximum Number of Screws

ACTIVE COMPARATOR

Once enrolled and consented, patients with Lenke 1A curves will be randomized to a high- or low-density screw cohort. The high-density pattern will be designated as ≥ 1.8 implants per level fused. The low density pattern will be ≤ 1.4 screws per level fused. At least 75% of the implants must be pedicle screws for both cohorts.

Procedure: Maximum Number of Screws

Minimum Number of Screws

ACTIVE COMPARATOR

Once enrolled and consented, patients with Lenke 1A curves will be randomized to a high- or low-density screw cohort. The high-density pattern will be designated as ≥ 1.8 implants per level fused. The low density pattern will be ≤ 1.4 screws per level fused. At least 75% of the implants must be pedicle screws for both cohorts.

Procedure: Minimum Number of Screws

Interventions

Maximum Number of ScrewsPROCEDURE

The tools used for this arm of study are FDA approved with section 510 (k) K122433. These screws are regularly used in all procedures pertaining to Cobb angle correction surgeries outside of the context of this study.

Also known as: Pedicle Screw Spinal System
Maximum Number of Screws
Minimum Number of ScrewsPROCEDURE

The tools used for this arm of study are FDA approved with section 510 (k) K122433. These screws are regularly used in all procedures pertaining to Cobb angle correction surgeries outside of the context of this study.

Also known as: Pedicle Screw Spinal System
Minimum Number of Screws

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients aged ≥10 and ≤ 18 years
  • Male or Female
  • Diagnosis of idiopathic scoliosis for which surgery is recommended to prevent the curvature or to correct trunk disfigurement Lenke 1A curve pattern
  • Curve cobb of 45° to 65°
  • T5-T12 kyphosis measuring 0° to 40°
  • Spina bifida Oculta is permitted
  • Spondylolisthesis and Spondylolysis are permitted, as long as non- operative

You may not qualify if:

  • Prior spinal surgery
  • MRI abnormalities (including \>4mm of Syrinx and/or Chiari malformation)
  • Neuromuscular or other serious co-morbidities
  • Thoracogenic or cardiogenic scoliosis
  • Associated syndrome or developmental delay
  • Unable or unwilling to firmly commit to returning for required follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Nemours/ Alfred I. duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Children's Research Institute

Washington D.C., District of Columbia, 20010-2916, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Norton Leatherman Spine Center

Louisville, Kentucky, 40207, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

The Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

University of Rochester

Rochester, New York, 14618, United States

Location

Texas Scottish Rite Hospital for Children

Dallas, Texas, 75219, United States

Location

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, H3T1C5, Canada

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • David W Polly, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2013

First Posted

February 15, 2013

Study Start

April 18, 2013

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

August 3, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)US(13)