Degenerative Scoliosis Clinical Trial
— DLSOfficial title:
Degenerative Lumbar Scoliosis: a Multi-center Study
NCT number | NCT05485636 |
Other study ID # | M2022381 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 1, 2022 |
Est. completion date | August 1, 2024 |
This is a retrospective, observational multi-center study. The participants undergone lumbar spine surgery for degenerative lumbar scoliosis and followed up for at least 2 years are retrospectively enrolled from 8 centers. This study mainly focuses on the short-term and long-term outcomes of lumbar surgery in participants with degenerative lumbar scoliosis, and that how much the surgical outcomes are related with demographic, surgical, and radiographic features before and after surgery. The objective is to offer more detailed clinical evidence to guide the surgical strategy development for degenerative lumbar scoliosis.
Status | Recruiting |
Enrollment | 640 |
Est. completion date | August 1, 2024 |
Est. primary completion date | August 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: - age = 60 years old - diagnosed with degenerative lumbar scoliosis with X-ray before surgery - Cobb angle of the major curve = 20° - with signs and/or symptoms of low back pain and/or leg pain, torso imbalance, and spinal nerve compression - followed up for at least 2 years after the surgery Exclusion Criteria: - scoliosis caused by infection, trauma or tumor. - classified as adult idiopathic scoliosis, congenital scoliosis, and scoliosis caused by neuromuscular diseases - previous history of spinal surgery |
Country | Name | City | State |
---|---|---|---|
China | Peking University Third Hospital | Beijing | Beijing |
China | West China Hospital of Sichuan University | Chengdu | Sichuan |
China | Qilu Hospital of Shandong University | Jinan | Shandong |
China | The First People's Hospital of Yunnan Province | Kunming | Yunnan |
China | The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi |
China | The Third Affiliated Hospital of Hebei Medical University | Shijiazhuang | Hebei |
China | Tianjin Hospital | Tianjin | Tianjin |
China | Henan Provincial People's Hospital | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Peking University Third Hospital | Hebei Medical University Third Hospital, Henan Provincial People's Hospital, Qilu Hospital of Shandong University, The First Affiliated Hospital of Nanchang University, The First People's Hospital of Yunnan, Tianjin Hospital, West China Hospital |
China,
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Protopsaltis T, Schwab F, Bronsard N, Smith JS, Klineberg E, Mundis G, Ryan DJ, Hostin R, Hart R, Burton D, Ames C, Shaffrey C, Bess S, Errico T, Lafage V; International Spine Study Group. TheT1 pelvic angle, a novel radiographic measure of global sagittal deformity, accounts for both spinal inclination and pelvic tilt and correlates with health-related quality of life. J Bone Joint Surg Am. 2014 Oct 1;96(19):1631-40. doi: 10.2106/JBJS.M.01459. — View Citation
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Wang H, Li W. Multilevel extended posterior column osteotomy plus unilateral cage strutting for degenerative lumbar kyphoscoliosis. Int Orthop. 2020 Jul;44(7):1375-1383. doi: 10.1007/s00264-020-04632-8. Epub 2020 May 21. — View Citation
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mechanical complications | Mechanical complications at the last follow-up, including proximal junctional kyphosis, proximal junctional failure, distal junctional kyphosis, distal junctional failure, instrument breakage, pedicle screw loosening, pseudoarthrosis, and others. | 24 months | |
Secondary | Radiological angular parameters | Radiological angular parameters measured on anteroposterior and lateral radiographs, including: 1) major and lumbosacral Cobb angle, 2) L4, L5 and upper instrumented vertebra (UIV) tilt, 3)T1-UIV Cobb angle, 4) thoracic kyphosis, 5) lumbar lordosis, 6) thoracolumbar kyphosis, 7) T1 pelvic angle, 8) pelvic incidence, 9) pelvic tilt, 10) sacral slope, 11) lordosis tilt, 12) proximal junctional angle, and 13) L4-S1 lumbar lordosis. | 3 months, 6 months, 12 months, 24 months | |
Secondary | Radiological distance parameters | Radiological distance parameters measured on anteroposterior and lateral radiographs, including: 1) coronal balance distance, 2) sagittal vertical axis, 3) apical vertebral translation. | 3 months, 6 months, 12 months, 24 months | |
Secondary | Back pain | The Visual Analogue Scale (VAS 0-10) is adopted to evaluate back pain, with higher scores indicating severer pain. | 3 months, 6 months, 12 months, 24 months | |
Secondary | Leg pain | The Visual Analogue Scale (VAS 0-10) is adopted to evaluate leg pain, with higher scores indicating severer pain. | 3 months, 6 months, 12 months, 24 months | |
Secondary | Disability | The Japanese Orthopaedic Association (JOA 0-29) Scores is used to assess disability, with lower scores indicating severer disability. The Oswestry Disability Index (ODI 0-100%) is also used to assess disability, with higher percentages indicating severer disability. | 3 months, 6 months, 12 months, 24 months |
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