Clinical Trials Directory

Trials / Completed

CompletedNCT02388555

Perspective Analysis of Coronal Imbalance in Degenerative Scoliosis

Coronal Imbalance in Degenerative Lumbar Scoliosis

Status
Completed
Phase
Study type
Observational
Enrollment
284 (actual)
Sponsor
Nanjing University School of Medicine · Academic / Other
Sex
All
Age
50 Years – 82 Years
Healthy volunteers
Not accepted

Summary

Currently there is paucity of information on the prevalence of pre-operative coronal imbalance in patients with degenerative lumbar scoliosis (DLS) and its influence on surgical outcomes. This study aims to investigate in DLS, the prevalence of coronal imbalance, to propose a novel classification system and to investigate whether pre-operative coronal imbalance affects clinical outcomes following osteotomy. A total of 284 DLS patients were recruited.

Detailed description

A total of 284 DLS patients were recruited into this two-stage study, among which 69 patients were treated by posterior-only correction and the remaining 215 patients received conservative treatment. Using pre-operative long-cassette X-ray films, all patients were classified based on coronal balance distance (CBD) defined as the horizontal distance between C7 plumb line and central sacral vertical line: Type A, CBD \< 3cm; Type B, CBD \> 3cm and C7PL shifts to the concave side of curve; Type C, CBD \> 3cm and C7PL shifts to the convex side of curve. The prevalence of pre-operative coronal imbalance was calculated for stage I study. Post-operative CBD in patients who received surgery was measured to evaluate clinical outcomes for stage II study.

Conditions

Interventions

TypeNameDescription
PROCEDUREPosterior osteotomy correctionThe DLS patients underwent osteotomy including pedicle subtraction osteotomy (PSO) or Smith-Petersen osteotomy (SPO)

Timeline

Start date
2010-01-01
Primary completion
2014-11-01
Completion
2015-01-01
First posted
2015-03-17
Last updated
2015-04-08

Source: ClinicalTrials.gov record NCT02388555. Inclusion in this directory is not an endorsement.

Perspective Analysis of Coronal Imbalance in Degenerative Scoliosis (NCT02388555) · Clinical Trials Directory