Impact of Metal Density on Deformity Correction for Adolescent Idiopathic Scoliosis

NCT ID: NCT04175145

Last Updated: 2019-11-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 96 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-12-31

Brief Summary

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

Detailed Description

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.

Conditions

Adolescent Idiopathic Scoliosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Posterior spinal instrumentation

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ghurki Trust and Teaching Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Irfan Qadir

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopaedics and Spine Surgery, Ghurki Trust Teaching Hospital

Prof.Amer Aziz, Professor and Chief

Role: STUDY_DIRECTOR

Department of Orthopaedics and Spine Surgery, Ghurki Trust Teaching Hospital

Abdullah Shah, Assistant Professor

Role: STUDY_CHAIR

Department of Orthopaedics and Spine Surgery, Ghurki Trust Teaching Hospital

Syed Roman Alam, Resident

Role: STUDY_CHAIR

Department of Orthopaedics and Spine Surgery, Ghurki Trust Teaching Hospital

Haseeb Hussain, Senior Registrar

Role: STUDY_CHAIR

Department of Orthopaedics and Spine Surgery, Ghurki Trust Teaching Hospital

Prof.Rizwan Akram, Professor

Role: STUDY_CHAIR

Department of Orthopaedics and Spine Surgery, Ghurki Trust Teaching Hospital

Other Identifiers

19

Identifier Type: -

Identifier Source: org_study_id