Clinical trial NCT04175145: Impact of Metal Density on Deformity Correction for Adolescent Idiopathic Scoliosis
Official title: Impact of Metal Density on Deformity Correction in Posterior Fusions for Adolescent Idiopathic Scoliosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adolescent Idiopathic Scoliosis
Keywords: Adolescent idiopathic scoliosis
posterior instrumentation
metal density
correction
Pakistan
Lead sponsor: Ghurki Trust and Teaching Hospital
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 96
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective review of all patients with Adolescent Idiopathic Scoliosis patients operated at our hospital during study period

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.

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

Primary outcomes:
measure: Degree of correction achieved
timeFrame: 2 years
measure: Cobb angle
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Orthopaedics and Spine Surgery, Ghurki Trust Teaching Hospital
name: Dr Irfan Qadir
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Orthopaedics and Spine Surgery, Ghurki Trust Teaching Hospital
name: Prof.Amer Aziz, Professor and Chief
role: STUDY_DIRECTOR
affiliation: Department of Orthopaedics and Spine Surgery, Ghurki Trust Teaching Hospital
name: Abdullah Shah, Assistant Professor
role: STUDY_CHAIR
affiliation: Department of Orthopaedics and Spine Surgery, Ghurki Trust Teaching Hospital
name: Syed Roman Alam, Resident
role: STUDY_CHAIR
affiliation: Department of Orthopaedics and Spine Surgery, Ghurki Trust Teaching Hospital
name: Haseeb Hussain, Senior Registrar
role: STUDY_CHAIR
affiliation: Department of Orthopaedics and Spine Surgery, Ghurki Trust Teaching Hospital
name: Prof.Rizwan Akram, Professor
role: STUDY_CHAIR
References: