Clinical Study of Imaging and Endoplant-related Mechanical Complications After Long Segment Fixation and Fusion of Degenerative Lumbar Scoliosis (DLS)

NCT04960423 | Unknown

• 1 other identifier: LM2018106
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

There is a high probability of mechanical complications in patients with degenerative lumbar scoliosis after long segment fixation and fusion, and there are few studies on distal borderline kyphosis deformity/failure. This study was designed to retrospectively analyze the patients with degenerative lumbar scoliosis (DLS) who underwent posterior selective decompression and long segment fixation and fusion surgery in the lumbar spine department of our hospital from April 2009 to May 2016. Patients' basic data, surgical data and preoperative, immediate postoperative and follow-up imaging data were collected to study the incidence of distal mechanical complications, risk factors and their relationship with clinical symptom scores in DLS patients undergoing posterior selective decompression and long segment fixation and fusion. It has guiding significance for clinical operation decision making.

Conditions

Degenerative Scoliosis

Outcome Measures

Primary Outcomes (1)

• Imaging and Endoplant-related Mechanical Complications

  PJK, DJK

  2019.1.1-2025.12.31

Interventions

Long Segment Fixation and Fusion PROCEDURE

Long Segment Fixation and Fusion

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

From April 2009 to May 2019, patients with degenerative lumbar scoliosis (DLS) underwent posterior selective decompression and long segment fixation and fusion surgery in the Department of Orthopaedic Lumbar Surgery of our hospital

You may qualify if:

• Age ≥45 years old;
• The number of fixed vertebral bodies ≥5, and the upper instrumented vertebra (UIV) is located in the thoracolumbar segment;
• Third generation total pedicle screw internal fixation system;
• Follow-up time ≥24 months;
• Complete clinical and imaging data.

You may not qualify if:

• Idiopathic scoliosis, neuromuscular scoliosis, non-structural scoliosis, spinal tumors, spinal tuberculosis, ankylosing spondylitis, humman's disease, history of spinal surgery, history of spinal trauma, and history of hip surgery

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University of Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Interventions

Gene Fusion

Intervention Hierarchy (Ancestors)

Recombination, Genetic; Genetic Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2021
• First Posted: July 13, 2021
• Study Start: January 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2025
• Last Updated: July 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)