Perspective Analysis of Coronal Imbalance in Degenerative Scoliosis

Completed

• Conditions: Scoliosis
• Interventions: Procedure: Posterior osteotomy correction

• Registration Number: NCT02388555
• Lead Sponsor: Nanjing University School of Medicine

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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2014-11
• Study Completion: 2015-01
• Study First Submitted: 2015-02-04
• Study First Submitted QC: 2015-03-09
• Study First Posted: 2015-03-17
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 284

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgically treated group	Posterior osteotomy correction	All DLS patients received posterior osteotomy correction of spinal deformity. The immediate post-operative radiographic measurements were performed.

Primary Outcome Measures

Name	Time	Method
The relationship between coronal balance classification and immediate post-operative imbalance using radiographic measurements	Up to 3 months	This 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 Outcome Measures

Name	Time	Method
Prevalence of coronal imbalance in degenerative scoliosis using radiographic measurements	Up to 2 year pre-operative follow-up	The 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.
Relationship between post-operative imbalance and quality of life using quality of life questionnaires including SF-36, ODI and VAS	Up to 1 year	The 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.