Degenerative Lumbar Scoliosis

• Conditions: Degenerative Scoliosis; Scoliosis Lumbar Region

• Registration Number: NCT05485636
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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.

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 Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-04
• Study Start: 2022-08-01
• Study First Submitted QC: 2022-08-02
• Study First Posted: 2022-08-03
• Last Update Submitted: 2022-11-29
• Last Update Posted: 2022-12-01
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 640

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mechanical complications	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.

Secondary Outcome Measures

Name	Time	Method
Back pain	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.
Radiological distance parameters	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.
Radiological angular parameters	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.
Leg pain	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.
Disability	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.

Trial Locations

Locations (8)

Henan Provincial People's Hospital; 🇨🇳 Zhengzhou, Henan, China

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China

The First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

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

The Third Affiliated Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China

The First People's Hospital of Yunnan Province; 🇨🇳 Kunming, Yunnan, China

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Tianjin Hospital; 🇨🇳 Tianjin, Tianjin, China