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

Degenerative Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04960423
• Other study ID #: LM2018106
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2021
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Degenerative Scoliosis
• Scoliosis

Intervention

Procedure:
• Long Segment Fixation and Fusion
Long Segment Fixation and Fusion

Locations

Country	Name	City	State
China	Peking University of Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Imaging and Endoplant-related Mechanical Complications	PJK, DJK	2019.1.1-2025.12.31