Degenerative Lumbar Scoliosis

NCT05485636 | Unknown

• 1 other identifier: M2022381
• Study Type: observational
• Target: 640
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Degenerative Scoliosis; Scoliosis Lumbar Region

Keywords

degenerative, lumbar, scoliosis, outcome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Radiological angular parameters

  3 months, 6 months, 12 months, 24 months

• Radiological distance parameters

  3 months, 6 months, 12 months, 24 months

• Back pain

  3 months, 6 months, 12 months, 24 months

• Leg pain

  3 months, 6 months, 12 months, 24 months

• Disability

  3 months, 6 months, 12 months, 24 months

Study Arms (1)

degenerative lumbar scoliosis postoperative group

This group contains patients who have undergone spinal surgery for degenerative lumbar scoliosis. No interventions are designed to be administered.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In the orthopaedic department of the eight medical centers, patients undergone spinal surgery for degenerative lumbar scoliosis are invited to participate in the study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Hebei Medical University Third Hospital: collaborator
• Tianjin Hospital: collaborator
• West China Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• Henan Provincial People's Hospital: collaborator
• The First People's Hospital of Yunnan: collaborator

Study Sites (8)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

The Third Affiliated Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050051, China

RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330019, China

RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Tianjin Hospital

Tianjin, Tianjin Municipality, 300210, China

RECRUITING

The First People's Hospital of Yunnan Province

Kunming, Yunnan, 650032, China

RECRUITING

Related Publications (23)

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• Xu L, Sun X, Huang S, Zhu Z, Qiao J, Zhu F, Mao S, Ding Y, Qiu Y. Degenerative lumbar scoliosis in Chinese Han population: prevalence and relationship to age, gender, bone mineral density, and body mass index. Eur Spine J. 2013 Jun;22(6):1326-31. doi: 10.1007/s00586-013-2678-8. Epub 2013 Jan 30.

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• Schwab F, Dubey A, Gamez L, El Fegoun AB, Hwang K, Pagala M, Farcy JP. Adult scoliosis: prevalence, SF-36, and nutritional parameters in an elderly volunteer population. Spine (Phila Pa 1976). 2005 May 1;30(9):1082-5. doi: 10.1097/01.brs.0000160842.43482.cd.

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• Jimbo S, Kobayashi T, Aono K, Atsuta Y, Matsuno T. Epidemiology of degenerative lumbar scoliosis: a community-based cohort study. Spine (Phila Pa 1976). 2012 Sep 15;37(20):1763-70. doi: 10.1097/BRS.0b013e3182575eaa.

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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.

  PMID: 25274788 BACKGROUND

• Diebo BG, Oren JH, Challier V, Lafage R, Ferrero E, Liu S, Vira S, Spiegel MA, Harris BY, Liabaud B, Henry JK, Errico TJ, Schwab FJ, Lafage V. Global sagittal axis: a step toward full-body assessment of sagittal plane deformity in the human body. J Neurosurg Spine. 2016 Oct;25(4):494-499. doi: 10.3171/2016.2.SPINE151311. Epub 2016 May 20.

  PMID: 27203811 BACKGROUND

• Bao H, Yan P, Qiu Y, Liu Z, Zhu F. Coronal imbalance in degenerative lumbar scoliosis: Prevalence and influence on surgical decision-making for spinal osteotomy. Bone Joint J. 2016 Sep;98-B(9):1227-33. doi: 10.1302/0301-620X.98B9.37273.

  PMID: 27587525 BACKGROUND

• Wang H, Wang L, Sun Z, Jiang S, Li W. Posterior column osteotomy plus unilateral cage strutting for correction of lumbosacral fractional curve in degenerative lumbar scoliosis. J Orthop Surg Res. 2020 Oct 20;15(1):482. doi: 10.1186/s13018-020-02011-y.

  PMID: 33081812 BACKGROUND

• Schwab FJ, Smith VA, Biserni M, Gamez L, Farcy JP, Pagala M. Adult scoliosis: a quantitative radiographic and clinical analysis. Spine (Phila Pa 1976). 2002 Feb 15;27(4):387-92. doi: 10.1097/00007632-200202150-00012.

  PMID: 11840105 BACKGROUND

• Schwab FJ, Blondel B, Bess S, Hostin R, Shaffrey CI, Smith JS, Boachie-Adjei O, Burton DC, Akbarnia BA, Mundis GM, Ames CP, Kebaish K, Hart RA, Farcy JP, Lafage V; International Spine Study Group (ISSG). Radiographical spinopelvic parameters and disability in the setting of adult spinal deformity: a prospective multicenter analysis. Spine (Phila Pa 1976). 2013 Jun 1;38(13):E803-12. doi: 10.1097/BRS.0b013e318292b7b9.

  PMID: 23722572 BACKGROUND

• Schwab F, Blondel B, Chay E, Demakakos J, Lenke L, Tropiano P, Ames C, Smith JS, Shaffrey CI, Glassman S, Farcy JP, Lafage V. The comprehensive anatomical spinal osteotomy classification. Neurosurgery. 2014 Jan;74(1):112-20; discussion 120. doi: 10.1227/NEU.0000000000000182o.

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• Toyone T, Shiboi R, Ozawa T, Inada K, Shirahata T, Kamikawa K, Watanabe A, Matsuki K, Ochiai S, Kaiho T, Morikawa Y, Sota K, Yasuchika A, Gen I, Sumihisa O, Ohtori S, Takahashi K, Wada Y. Asymmetrical pedicle subtraction osteotomy for rigid degenerative lumbar kyphoscoliosis. Spine (Phila Pa 1976). 2012 Oct 1;37(21):1847-52. doi: 10.1097/BRS.0b013e31825bf644.

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• Chan AK, Lau D, Osorio JA, Yue JK, Berven SH, Burch S, Hu SS, Mummaneni PV, Deviren V, Ames CP. Asymmetric Pedicle Subtraction Osteotomy for Adult Spinal Deformity with Coronal Imbalance: Complications, Radiographic and Surgical Outcomes. Oper Neurosurg. 2020 Feb 1;18(2):209-216. doi: 10.1093/ons/opz106.

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• Buchowski JM, Bridwell KH, Lenke LG, Kuhns CA, Lehman RA Jr, Kim YJ, Stewart D, Baldus C. Neurologic complications of lumbar pedicle subtraction osteotomy: a 10-year assessment. Spine (Phila Pa 1976). 2007 Sep 15;32(20):2245-52. doi: 10.1097/BRS.0b013e31814b2d52.

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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.

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• Schwab F, Ungar B, Blondel B, Buchowski J, Coe J, Deinlein D, DeWald C, Mehdian H, Shaffrey C, Tribus C, Lafage V. Scoliosis Research Society-Schwab adult spinal deformity classification: a validation study. Spine (Phila Pa 1976). 2012 May 20;37(12):1077-82. doi: 10.1097/BRS.0b013e31823e15e2.

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• Smith JS, Singh M, Klineberg E, Shaffrey CI, Lafage V, Schwab FJ, Protopsaltis T, Ibrahimi D, Scheer JK, Mundis G Jr, Gupta MC, Hostin R, Deviren V, Kebaish K, Hart R, Burton DC, Bess S, Ames CP; International Spine Study Group. Surgical treatment of pathological loss of lumbar lordosis (flatback) in patients with normal sagittal vertical axis achieves similar clinical improvement as surgical treatment of elevated sagittal vertical axis: clinical article. J Neurosurg Spine. 2014 Aug;21(2):160-70. doi: 10.3171/2014.3.SPINE13580. Epub 2014 Apr 25.

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• Fei H, Li WS, Sun ZR, Jiang S, Chen ZQ. Effect of patient position on the lordosis and scoliosis of patients with degenerative lumbar scoliosis. Medicine (Baltimore). 2017 Aug;96(32):e7648. doi: 10.1097/MD.0000000000007648.

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• Han F, Weishi L, Zhuoran S, Qingwei M, Zhongqiang C. Sagittal plane analysis of the spine and pelvis in degenerative lumbar scoliosis. J Orthop Surg (Hong Kong). 2017 Jan;25(1):2309499016684746. doi: 10.1177/2309499016684746.

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• Xu F, Sun Z, Li W, Hou X, Jiang S, Zhou S, Zou D, Li Z. Correlation between lordosis distribution index, lordosis tilt, and occurrence of proximal junctional kyphosis following surgery for adult degenerative scoliosis. Eur Spine J. 2022 Feb;31(2):267-274. doi: 10.1007/s00586-021-07090-x. Epub 2022 Jan 25.

  PMID: 35075515 BACKGROUND

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Weishi Li, M.D.

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weishi Li, M.D.

CONTACT

(+86010)62017691-7011; puh3liweishi@163.com

Zhuoran Sun, M.D.

CONTACT

puh3_szr@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: August 3, 2022
• Study Start: August 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: December 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: The IPD will become available half a year after the publication of the results of the study.
• Access Criteria: The IPD is available to the readers of the journal in which our research is published. The corresponding author of the published papers will review the requests.

Locations

CN (8)