Paraspinal Muscle Degeneration, Bone Mass and Clinical Outcomes in Patients With Lumbar Degenerative Diseases

December 28, 2021 updated by: Peking University Third Hospital

The Relationship Between Paraspinal Muscle Degeneration and Bone Mass and Clinical Outcomes After Surgery in Patients With Lumbar Degenerative Diseases

This study was a retrospective study. The investigators intended to review the preoperative paraspinal muscle imaging data of patients with lumbar spinal stenosis and degenerative scoliosis treated in hospital, and follow up the symptoms, quality of life and surgical complications at 1 year and at the last follow-up. The aims were: (1) to explore the correlation between paraspinal muscle imaging parameters and clinical outcomes; (2) based on the postoperative functional scores and the presence of complications, to explore the best combination of imaging parameters for predictive value of prognosis; (3) to evaluate the consistency between different measurement methods, and improve the standardized paraspinal muscle imaging assessment; (4) Combining the characteristics of individual bone mass and paravertebral muscle (functional and imaging assessment), to explore the correlation between bone loss and paravertebral muscle degeneration; (5) to explore a muscle-bone mass assessment system that could reflect the prognosis of patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study was a retrospective study. The investigators intended to review the preoperative paraspinal muscle imaging data of patients with lumbar spinal stenosis and degenerative scoliosis treated in our hospital, and follow up the symptoms, quality of life and surgical complications at 1 year and at the last follow-up. The aims were: (1) to explore the correlation between paraspinal muscle imaging parameters and clinical outcomes; (2) based on the postoperative functional scores and the presence of complications, to explore the best combination of imaging parameters for predictive value of prognosis; (3) to evaluate the consistency between different measurement methods, and improve the standardized paraspinal muscle imaging assessment; (4) Combining the characteristics of individual bone mass and paravertebral muscle (functional and imaging assessment), to explore the correlation between bone loss and paravertebral muscle degeneration; (5) to explore a muscle-bone mass assessment system that could reflect the prognosis of patients.

The investigators intended to review the patients who underwent posterior surgery for degenerative lumbar diseases from January 2010 to December 2019.

  1. To review the patients who underwent posterior surgery in orthopedic department for degenerative scoliosis. The inclusion criteria were: (1) above the age of 45; (2) satisfy at least one of the following criteria: cobb angle > 10°, sagittal vertical axis (SVA) > 5cm, pelvic tilt (PT) > 25°, or thoracic kyphosis (TK) > 60°. The exclusion criteria were: (1) with a history of arthritic tumor or neuromuscular disease (2) with a history of spinal surgery.
  2. To review the patients who underwent posterior surgery in orthopedic department for lumbar spinal stenosis. The inclusion criteria were: (1) above the age of 45; (2) diagnosis of lumbar spinal stenosis. The exclusion criteria were: (1) with a history of arthritic tumor or neuromuscular disease (2) with a history of spinal surgery.

Study Type

Observational

Enrollment (Anticipated)

600

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 Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • 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

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

In the orthopaedic department of Peking University Third Hospital, patients with a clear diagnosis of lumbar degenerative diseases, and were performed by posterior surgery will be enrolled.

Description

Inclusion Criteria:

  • Underwent posterior surgery for degenerative scoliosis;
  • Above the age of 45;
  • Satisfy at least one of the following criteria: cobb angle > 10°, sagittal vertical axis > 5cm, pelvic tilt > 25°, or thoracic kyphosis > 60°.

Exclusion Criteria:

  • Underwent posterior surgery for lumbar spinal stenosis;
  • Above the age of 45;
  • Diagnosis of lumbar spinal stenosis.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Compared Group
Patients without inferior clinical outcomes
Other: Pre-existing degenerative factors of paraspinal muscles and bone mass
Pre-existing degenerative factors of paraspinal muscles, including muscle atrophy and fat infiltration; bone mass
Case Group
Patients with inferior clinical outcomes
Other: Pre-existing degenerative factors of paraspinal muscles and bone mass
Pre-existing degenerative factors of paraspinal muscles, including muscle atrophy and fat infiltration; bone mass

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability
Time Frame: 12 months; through study completion, an average of 3 years
The Oswestry Disability Index (ODI) (0-100, high score indicates severer disability) is used to assess disability.
12 months; through study completion, an average of 3 years
Low Back pain
Time Frame: 12 months; through study completion, an average of 3 years
The Visual Analog Scale (VAS) (0-10, high score indicates more pain) is used to evaluate leg pain.
12 months; through study completion, an average of 3 years
Leg pain
Time Frame: 12 months; through study completion, an average of 3 years
The Visual Analog Scale (VAS) (0-10, high score indicates more pain) is used to evaluate leg pain.
12 months; through study completion, an average of 3 years
Sagittal balance
Time Frame: 12 months; through study completion, an average of 3 years
Sagittal balance is evaluated by anteroposterior and lateral X-ray of the whole spine at the standing position.
12 months; through study completion, an average of 3 years
Bone nonunion
Time Frame: 12 months; through study completion, an average of 3 years
Bone nonunion was evaluated by dynamic X-ray. Bone nonunion was defined as 1) there was no continued bone fusion mass at any fusion segment; 2) any motion (greater than 3 mm or 3°) on flexion/ extension plain radiographs.
12 months; through study completion, an average of 3 years
Screw loosening
Time Frame: 12 months; through study completion, an average of 3 years
Screw loosening was evaluated on spine radiograph or CT. Screw loosening was defined when a 1mm or wider circumferential radiolucent line around the pedicle screw was confirmed.
12 months; through study completion, an average of 3 years
Proximal junctional kyphosis
Time Frame: 12 months; through study completion, an average of 3 years
Proximal junctional angle (PJA) was determined by the sagittal angle subtended by the inferior endplate of the uppermost instrumented vertebra (UIV) and the superior end plate of the vertebrae two levels above the UIV (UIV + 2). The definition of proximal junctional kyphosis (PJK) was PJA 10 or greater and at least 10 greater than the corresponding preoperative measurement.
12 months; through study completion, an average of 3 years
Proximal scoliosis progression
Time Frame: 12 months; through study completion, an average of 3 years
The proximal scoliosis progression (PSP) was defined as the disc wedging increased 10 degrees from postoperative to two-year follow up on the AP radiograph.
12 months; through study completion, an average of 3 years

Collaborators and Investigators

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

Sponsor

Peking University Third Hospital

Investigators

  • Principal Investigator: Wei-Shi Li, M.D., Peking University Third Hospital

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)

April 3, 2021

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 30, 2022

Study Registration Dates

First Submitted

June 27, 2021

First Submitted That Met QC Criteria

December 28, 2021

First Posted (Actual)

January 13, 2022

Study Record Updates

Last Update Posted (Actual)

January 13, 2022

Last Update Submitted That Met QC Criteria

December 28, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M2021134

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 for half a year after the publication of the results of the study.

IPD Sharing Time Frame

The individual participant data (IPD) will become available for 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

  • 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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