An observational study in Scoliosis, sponsored by Nanjing University School of Medicine. Completed. Open to participants aged 50 Years to 82 Years. Per ClinicalTrials.gov, last updated 2015-04-08.
Sponsored by Nanjing University School of Medicine · Observational
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.
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.
594 studies on the registry are indexed under Scoliosis; 139 are open to participants now.
This study's enrollment of 284 is above the median of 89 across 233 observational studies indexed under Scoliosis.
Browse Scoliosis studies →Nanjing University School of Medicine is the lead sponsor of 37 studies on the registry; 5 are open to participants now.
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Patients with degenerative scoliosis
age > 50 years, diagnosis of DLS based on radiographies and previous medical history and Cobb angle >25°.
Exclusion Criteria:
-
Respectively recruited patients with DLS. Patients in this group were not surgically treatment. Only pre-operative radiographic parameters were measured.
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)
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.
Time frame: Up to 3 months
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.
Time frame: Up to 1 year
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.
Time frame: Up to 2 year pre-operative follow-up
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This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Nanjing University School of Medicine