DLSDegenerative Lumbar Scoliosis: a Multi-center Study
Data Collection
Collected from past medical records and data - RetrospectiveBone Diseases+2
+ Musculoskeletal Diseases
+ Scoliosis
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: August 1, 2022
Actual date on which the first participant was enrolled.Degenerative lumbar scoliosis is a spinal deformity that typically develops among adults over 50 years old. Characterized with low back pain, leg pain and abnormal body posture to various degrees, patients are mostly offered conservative treatment in early stages, and then resort to surgical treatment when medication fail to achieve alleviation. The surgical procedures to treat degenerative lumbar scoliosis include spinal decompression, fusion, and instrumentation, or a combination of several of the above. Osteotomy is generally required when it comes to rigid deformity. However, surgical treatment strategies are complicated by factors comprising osteoporosis, paraspinal muscle degeneration, common yet severe postoperative complications resulting from specific surgical methods, and chronic metabolic diseases and so on. A detailed and individualized surgical planning has been under debate and development continuously. Also, most previous classifications and researches are centered on the population of the white. Representative data of the yellow people, especially Chinese people, from multicentric studies are scarce. Patients undergone surgeries for degenerative lumbar scoliosis in 8 hospitals in China between 2010 and 2020 are retrospectively selected and enrolled. Patients' clinical data from pre-operation, post-operation and the last follow-up are revaluated. General patient data are collected after informed consent, such as age, gender, height, weight, body mass index and bone mineral density measured in T-scores, together with surgical data including operation duration, blood loss, physical status grades based on the American Society of Anesthesiologists Classification, surgical approaches, upper instrumented vertebra, lowest instrumented vertebra, osteotomy grades based on Schwab Classification, osteotomy levels, lumbosacral curve levelling approaches, cemented vertebrae, and perioperative complications. Radiographic parameters of the spine are also measured from X-rays, including the upper end vertebra of the major curve, apical vertebral translation, Cobb angles of the major and fractional curves, coronal balance distance, coronal classification of the deformity based on the Drum Tower Classification, L4 and L5 tilt on the coronal plane, lumbar tilt, thoracic kyphosis, lumbar lordosis, thoracolumbar kyphosis, sagittal vertical axis, T1 pelvic angle, pelvic tilt, sacral slope, L4-S1 lordotic angle, and proximal junctional angle. Clinical outcomes assessed with Japanese Orthopaedic Association score, Oswestry Disability Index and visual analogue scale of leg/back pain are also gathered. Correlation between demographic, surgical, and radiographic parameters and clinical outcomes are statistically explored, in order to find indexes that help group and match patients with their optimum surgical strategies.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.640 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 8 locations
The Third Affiliated Hospital of Hebei Medical University
Shijiazhuang, ChinaHenan Provincial People's Hospital
Zhengzhou, ChinaThe First Affiliated Hospital of Nanchang University
Nanchang, China