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

• Conditions: Degenerative Lumbar Spinal Stenosis; Degenerative Scoliosis
• Interventions: Other: Pre-existing degenerative factors of paraspinal muscles and bone mass

• Registration Number: NCT05190289
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Study Start: 2021-04-03
• Status Verified: 2021-06
• Study First Submitted: 2021-06-27
• Study First Submitted QC: 2021-12-28
• Last Update Submitted: 2021-12-28
• Study First Posted: 2022-01-13
• Last Update Posted: 2022-01-13
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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°.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Compared Group	Pre-existing degenerative factors of paraspinal muscles and bone mass	Patients without inferior clinical outcomes
Case Group	Pre-existing degenerative factors of paraspinal muscles and bone mass	Patients with inferior clinical outcomes

Primary Outcome Measures

Name	Time	Method
Low Back pain	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.
Disability	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.
Leg pain	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.
Sagittal balance	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.
Bone nonunion	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.
Screw loosening	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.
Proximal scoliosis progression	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.
Proximal junctional kyphosis	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.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China