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Perspective Analysis of Coronal Imbalance in Degenerative Scoliosis

Coronal Imbalance in Degenerative Lumbar Scoliosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02388555
Enrollment
284
Registered
2015-03-17
Start date
2010-01-31
Completion date
2015-01-31
Last updated
2015-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis

Brief 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.

Interventions

PROCEDUREPosterior osteotomy correction

The DLS patients underwent osteotomy including pedicle subtraction osteotomy (PSO) or Smith-Petersen osteotomy (SPO)

Sponsors

Nanjing University School of Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 82 Years
Healthy volunteers
No

Inclusion criteria

age \> 50 years, diagnosis of DLS based on radiographies and previous medical history and Cobb angle \>25°.

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
The relationship between coronal balance classification and immediate post-operative imbalance using radiographic measurementsUp to 3 monthsThis part of the study aims to analyze the immediate imbalance after surgery, most of the patients took post-operative films two weeks after surgery, but there were some patients who could not stand at that timepoint and the follow-up time was then at 3 months after surgery.

Secondary

MeasureTime frameDescription
Relationship between post-operative imbalance and quality of life using quality of life questionnaires including SF-36, ODI and VASUp to 1 yearThe quality of life measurements were obtained using questionnaires, and the correlations between coronal imbalance and quality of life were analyzed at 1 year follow-up.
Prevalence of coronal imbalance in degenerative scoliosis using radiographic measurementsUp to 2 year pre-operative follow-upThe prevalence of coronal imbalance was analyzed in this cross-sectional study. Only a small part of the patients were with longitudinal follow-up. Most of them were without follow-up.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026