Perspective Analysis of Coronal Imbalance in Degenerative Scoliosis

Scoliosis Clinical Trial

Official title:

Coronal Imbalance in Degenerative Lumbar Scoliosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02388555
• Other study ID #: 2013-079-01
• Status: Completed
• Phase: N/A
• First received: February 4, 2015
• Last updated: April 7, 2015
• Start date: January 2010
• Est. completion date: January 2015

Study information

• Verified date: April 2015
• Source: Nanjing University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: January 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 82 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Scoliosis

Intervention

Procedure:
• Posterior osteotomy correction
The DLS patients underwent osteotomy including pedicle subtraction osteotomy (PSO) or Smith-Petersen osteotomy (SPO)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The relationship between coronal balance classification and immediate post-operative imbalance using radiographic measurements	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.	Up to 3 months	No
Secondary	Relationship between post-operative imbalance and quality of life using quality of life questionnaires including SF-36, ODI and VAS	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.	Up to 1 year	No
Secondary	Prevalence of coronal imbalance in degenerative scoliosis using radiographic measurements	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.	Up to 2 year pre-operative follow-up	No