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Completed

NCT Number: NCT04175145

Impact of Metal Density on Deformity Correction for Adolescent Idiopathic Scoliosis

A retrospective analysis to ascertain the correlation between metal density and deformity correction among individuals with adolescent idiopathic scoliosis.

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Key information

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Observational

About this study

Posterior spinal fusion with pedicle screws has become the "gold standard" for the management of adolescent idiopathic scoliosis (AIS). Pedicle screws provide three column fixation through the strongest part of vertebra thereby enhancing surgeon's ability to do a 3-dimensional deformity correction. The higher pullout strength results in less long-term loss of correction, shorter fusions resulting in preservation of motion segments, lower pseudarthrosis rates and lower implant failures compared with these alternative posterior instrumentation systems. However, studies are contradictoryregarding the effect of metal density on coronaland sagittal curve corrections. Multiple factors including curve flexibility, instrumentation and rod types, reduction strategies and curve types, affect outcomes. Given this, intraoperative decisions regarding the number of anchorage points remain difficult, with considerable inter-surgeon variability.

The rationale for using a high implant density constructs is to obtain more rigid fixation and to limit potential stress concentration at any one screw. Furthermore, health-related quality of life instruments such as the SRS 22, 24, or 30 seem to show little correlation with curve correction. The placement of every additional pedicle screw is associated with increased operative time, risk of neurological deterioration and increased implant cost. If implant density can be lowered without compromising clinical results, reducing the number of screws may improve the efficiency and cost effectiveness of scoliosis surgery. Several authors have demonstrated successful results with low-density instrumentation for the treatment of scoliosis. The purpose of this retrospective review is to describe the demographics of our patient population and to ascertain correlation between metal density and correction achieved.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with adolescent idiopathic scoliosis
  • Age more than 10 years at time of surgery
  • Posterior instrumentation consisting of all pedicle screw construct except for bilateral hooks at the uppermost instrumented vertebra
  • A major curve magnitude between 45 and 80 degrees.

Exclusion criteria

  • Scoliosis patients with a diagnosis other than adolescent idiopathic scoliosis
  • Previous spine surgery
  • Use of spinal osteotomies in addition to posterior spinal fusion with pedicle screws
  • ALenke 5 curve
  • Patients with less than 2 years' follow-up
  • Use of hooks or wires below the uppermost instrumented level

Treatment and study plan

Posterior spinal instrumentation

Other

A fusion construct consisting of all pedicle screws except at uppermost instrumented vertebra. Contoured dual 6-mm stainless steel rods were used to connect the construct. Pedicle screw location and density was determined by the surgeon based on perceived curve stiffness and fusion length with an even distribution of fixation points along the construct. Pedicle screw instrumentation was performed by the free hand technique with biplanar fluoroscopic and direct screw EMG impedance testing for confirmation of placement. Reduction was via cantilever-segmental-translation maneuver in all cases.

Primary outcomes

  1. Degree of correction achieved

    Time frame: 2 years

    (Preop Cobb angle - Postop Cobb angle/ Preop Cobb angle * 100)

  2. Cobb angle

    Time frame: 2 years

    Cobb angle is measured as angle sub-tented between the upper and lower end vertebrae (end vertebrae is defined as the vertebra that is most tilted from the horizontal apical vertebra)

Sponsors and collaborators

Lead sponsor

Ghurki Trust and Teaching Hospital

Other

Registry information

Official study title

Impact of Metal Density on Deformity Correction in Posterior Fusions for Adolescent Idiopathic Scoliosis

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 22, 2019
Registry last updated
Nov 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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