Min Implants Max Outcomes Clinical Trial

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.

Conditions

• Scoliosis
• Adolescent Idiopathic Scoliosis

Interventions

PROCEDURE

Maximum Number of Screws

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.

PROCEDURE

Minimum Number of Screws

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.

Sponsors & Collaborators

• Alfred I. duPont Hospital for Children

  collaborator OTHER

• Texas Scottish Rite Hospital for Children

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• University of Rochester

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Children's Hospital Colorado

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• University of Iowa

  collaborator OTHER

• Norton Leatherman Spine Center

  collaborator OTHER

• Children's Hospital of Philadelphia

  collaborator OTHER

• St. Justine's Hospital

  collaborator OTHER

• University of Minnesota

  lead OTHER

Principal Investigators

• David W Polly, MD · University of Minnesota

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

10 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-04-18

Primary Completion

2019-06-01

Completion

2019-06-01

Countries

• United States
• Canada

Study Locations