Perspective Analysis of Coronal Imbalance in Degenerative Scoliosis

April 7, 2015 updated by: Hongda Bao, Nanjing University School of Medicine

Coronal Imbalance in Degenerative Lumbar Scoliosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

284

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 82 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with degenerative scoliosis

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pre-operative group
Respectively recruited patients with DLS. Patients in this group were not surgically treatment. Only pre-operative radiographic parameters were measured.
Surgically treated group
All DLS patients received posterior osteotomy correction of spinal deformity. The immediate post-operative radiographic measurements were performed.
Procedure: Posterior osteotomy correction
The DLS patients underwent osteotomy including pedicle subtraction osteotomy (PSO) or Smith-Petersen osteotomy (SPO)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The relationship between coronal balance classification and immediate post-operative imbalance using radiographic measurements
Time Frame: 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.
Up to 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

February 4, 2015

First Submitted That Met QC Criteria

March 9, 2015

First Posted (Estimate)

March 17, 2015

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 7, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-079-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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