Degenerative Lumbar Scoliosis (DLS)

November 29, 2022 updated by: Peking University Third Hospital

Degenerative Lumbar Scoliosis: a Multi-center Study

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

640

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
    • Hebei
      • Shijiazhuang, Hebei, China, 050051
        • Recruiting
        • The Third Affiliated Hospital of Hebei Medical University
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Henan Provincial People's Hospital
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330019
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300210
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • Recruiting
        • The First People's Hospital of Yunnan Province
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

58 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mechanical complications
Time Frame: 24 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiological angular parameters
Time Frame: 3 months, 6 months, 12 months, 24 months
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
Radiological distance parameters
Time Frame: 3 months, 6 months, 12 months, 24 months
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
Back pain
Time Frame: 3 months, 6 months, 12 months, 24 months
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
Leg pain
Time Frame: 3 months, 6 months, 12 months, 24 months
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
Disability
Time Frame: 3 months, 6 months, 12 months, 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Anticipated)

August 1, 2024

Study Completion (Anticipated)

August 1, 2024

Study Registration Dates

First Submitted

July 4, 2022

First Submitted That Met QC Criteria

August 2, 2022

First Posted (Actual)

August 3, 2022

Study Record Updates

Last Update Posted (Actual)

December 1, 2022

Last Update Submitted That Met QC Criteria

November 29, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M2022381

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

We will make the clinical study report available half a year after the publication of the results of the study.

IPD Sharing Time Frame

The IPD will become available half a year after the publication of the results of the study.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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