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

NCT ID: NCT05190289

Last Updated: 2022-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-03
• Study Completion Date: 2022-09-30

Brief Summary

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.

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.

Conditions

Degenerative Lumbar Spinal Stenosis; Degenerative Scoliosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Compared Group

Patients without inferior clinical outcomes

Pre-existing degenerative factors of paraspinal muscles and bone mass

Intervention Type: OTHER

Pre-existing degenerative factors of paraspinal muscles, including muscle atrophy and fat infiltration; bone mass

Case Group

Patients with inferior clinical outcomes

Pre-existing degenerative factors of paraspinal muscles and bone mass

Intervention Type: OTHER

Pre-existing degenerative factors of paraspinal muscles, including muscle atrophy and fat infiltration; bone mass

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei-Shi Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Gengyu Han, M.D.

Role: CONTACT

475210693@qq.com

+86 15701206146

Facility Contacts

Gengyu Han, M.D.

Role: primary

475210693@qq.com

+86 15701206146

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Other Identifiers

M2021134

Identifier Type: -

Identifier Source: org_study_id