Trials / Completed
CompletedNCT02388555
Perspective Analysis of Coronal Imbalance in Degenerative Scoliosis
Coronal Imbalance in Degenerative Lumbar Scoliosis
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 284 (actual)
- Sponsor
- Nanjing University School of Medicine · Academic / Other
- Sex
- All
- Age
- 50 Years – 82 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Posterior osteotomy correction | The DLS patients underwent osteotomy including pedicle subtraction osteotomy (PSO) or Smith-Petersen osteotomy (SPO) |
Timeline
- Start date
- 2010-01-01
- Primary completion
- 2014-11-01
- Completion
- 2015-01-01
- First posted
- 2015-03-17
- Last updated
- 2015-04-08
Source: ClinicalTrials.gov record NCT02388555. Inclusion in this directory is not an endorsement.