Perspective Analysis of Coronal Imbalance in Degenerative Scoliosis

NCT ID: NCT02388555

Last Updated: 2015-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

284 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2015-01-31

Brief Summary

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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

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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

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Scoliosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pre-operative group

Respectively recruited patients with DLS. Patients in this group were not surgically treatment. Only pre-operative radiographic parameters were measured.

No interventions assigned to this group

Surgically treated group

All DLS patients received posterior osteotomy correction of spinal deformity. The immediate post-operative radiographic measurements were performed.

Posterior osteotomy correction

Intervention Type PROCEDURE

The DLS patients underwent osteotomy including pedicle subtraction osteotomy (PSO) or Smith-Petersen osteotomy (SPO)

Interventions

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Posterior osteotomy correction

The DLS patients underwent osteotomy including pedicle subtraction osteotomy (PSO) or Smith-Petersen osteotomy (SPO)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

50 Years

Maximum Eligible Age

82 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Hongda Bao

Ph.D. candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2013-079-01

Identifier Type: -

Identifier Source: org_study_id

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