Coronal Imbalance in Degenerative Lumbar Scoliosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 284
- Primary Endpoint
- The relationship between coronal balance classification and immediate post-operative imbalance using radiographic measurements
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to 82 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age > 50 years, diagnosis of DLS based on radiographies and previous medical history and Cobb angle >25°.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Prevalence of coronal imbalance in degenerative scoliosis using radiographic measurements(Up to 2 year pre-operative 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)
Investigators
Hongda Bao
Ph.D. candidate
Nanjing University School of Medicine