Impact of Metal Density on Deformity Correction for Adolescent Idiopathic Scoliosis

NCT04175145 | Completed

• 1 other identifier: 19
• Study Type: observational
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Adolescent idiopathic scoliosis; posterior instrumentation; metal density; correction; Pakistan

Outcome Measures

Primary Outcomes (2)

• Degree of correction achieved

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

  2 years

• Cobb angle

  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)

  2 years

Interventions

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.

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Retrospective review of all patients with Adolescent Idiopathic Scoliosis patients operated at our hospital during study period

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ghurki Trust and Teaching Hospital: lead

Study Officials

• Dr Irfan Qadir

  Department of Orthopaedics and Spine Surgery, Ghurki Trust Teaching Hospital

  PRINCIPAL INVESTIGATOR

• Prof.Amer Aziz, Professor and Chief

  Department of Orthopaedics and Spine Surgery, Ghurki Trust Teaching Hospital

  STUDY DIRECTOR

• Abdullah Shah, Assistant Professor

  Department of Orthopaedics and Spine Surgery, Ghurki Trust Teaching Hospital

  STUDY CHAIR

• Syed Roman Alam, Resident

  Department of Orthopaedics and Spine Surgery, Ghurki Trust Teaching Hospital

  STUDY CHAIR

• Haseeb Hussain, Senior Registrar

  Department of Orthopaedics and Spine Surgery, Ghurki Trust Teaching Hospital

  STUDY CHAIR

• Prof.Rizwan Akram, Professor

  Department of Orthopaedics and Spine Surgery, Ghurki Trust Teaching Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 22, 2019
• Study Start: January 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 22, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share