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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05190289
Enrollment
600
Registered
2022-01-13
Start date
2021-04-03
Completion date
2022-09-30
Last updated
2022-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Lumbar Spinal Stenosis, Degenerative Scoliosis

Keywords

Degenerative Lumbar Disease, Clinical Outcome, Complication, Paraspinal Muscle, Bone Mass

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.

Interventions

OTHERPre-existing degenerative factors of paraspinal muscles and bone mass

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

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Disability12 months; through study completion, an average of 3 yearsThe Oswestry Disability Index (ODI) (0-100, high score indicates severer disability) is used to assess disability.
Low Back pain12 months; through study completion, an average of 3 yearsThe Visual Analog Scale (VAS) (0-10, high score indicates more pain) is used to evaluate leg pain.
Leg pain12 months; through study completion, an average of 3 yearsThe Visual Analog Scale (VAS) (0-10, high score indicates more pain) is used to evaluate leg pain.
Sagittal balance12 months; through study completion, an average of 3 yearsSagittal balance is evaluated by anteroposterior and lateral X-ray of the whole spine at the standing position.
Bone nonunion12 months; through study completion, an average of 3 yearsBone 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 loosening12 months; through study completion, an average of 3 yearsScrew 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 junctional kyphosis12 months; through study completion, an average of 3 yearsProximal 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.
Proximal scoliosis progression12 months; through study completion, an average of 3 yearsThe proximal scoliosis progression (PSP) was defined as the disc wedging increased 10 degrees from postoperative to two-year follow up on the AP radiograph.

Countries

China

Contacts

Primary ContactGengyu Han, M.D.
475210693@qq.com+86 15701206146

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026