Perspective Analysis of Coronal Imbalance in Degenerative Scoliosis
Coronal Imbalance in Degenerative Lumbar Scoliosis
1 other identifier
observational
284
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2010
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 4, 2015
CompletedFirst Posted
Study publicly available on registry
March 17, 2015
CompletedApril 8, 2015
April 1, 2015
4.8 years
February 4, 2015
April 7, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Relationship between post-operative imbalance and quality of life using quality of life questionnaires including SF-36, ODI and VAS
Up to 1 year
Prevalence of coronal imbalance in degenerative scoliosis using radiographic measurements
Up to 2 year pre-operative follow-up
Study Arms (2)
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.
Interventions
The DLS patients underwent osteotomy including pedicle subtraction osteotomy (PSO) or Smith-Petersen osteotomy (SPO)
Eligibility Criteria
Patients with degenerative scoliosis
You may qualify if:
- age \> 50 years, diagnosis of DLS based on radiographies and previous medical history and Cobb angle \>25°.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ph.D. candidate
Study Record Dates
First Submitted
February 4, 2015
First Posted
March 17, 2015
Study Start
January 1, 2010
Primary Completion
November 1, 2014
Study Completion
January 1, 2015
Last Updated
April 8, 2015
Record last verified: 2015-04