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

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.

Study Overview

• Status: Recruiting
• Conditions: Degenerative Scoliosis
• Intervention / Treatment: Procedure: Long Segment Fixation and Fusion

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University of Third Hospital
      • Contact: Yan Zeng, M.D.; Phone Number: 7311 (+86010)62017691; Email: zy7311@sohu.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Imaging and Endoplant-related Mechanical Complications	PJK, DJK	2019.1.1-2025.12.31

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: July 4, 2021
• First Submitted That Met QC Criteria: July 12, 2021
• First Posted (Actual): July 13, 2021

Study Record Updates

• Last Update Posted (Actual): July 13, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: LM2018106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No