Assessing Risk Factors for Radiological Complications After Transforaminal Lumbar Interbody Fusion

NCT05266638 | Completed

• 1 other identifier: 2021-02227; mu22Netzer
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

This retrospective study is to determine whether age is a risk factor for postoperative complications in patients undergoing transforaminal lumbar interbody fusion; specifically whether the risk (odds) of implant failure and the need for revision surgery increases with age.

Conditions

Degenerative Lumbar Spine Diseases

Keywords

Posterior Lumbar Interbody Fusion (PLIF); Transforaminal Lumbar Interbody Fusion (TLIF); Implant Failure; Revision Surgery

Outcome Measures

Primary Outcomes (2)

• Number of Implant failure

  Number of Implant failure (screw loosening, cage subsidence, adjacent level alteration/ degeneration, spondylolisthesis degree, kyphosis of the adjacent intervertebral disc space, reduced height of intervertebral disc space) in relationship to age

  one time assessment at baseline

• Number of patients needing revision surgery

  Number of patients needing revision surgery, in relationship to age

  one time assessment at baseline

Interventions

Data collection (radiological parameters, outcome information) from electronic patient files in hospital data system OTHER

Collection of medical data and medical images (MRI, radiographs) of the lumbar spine and pelvis of patients having received TLIF with degenerative spinal diseases from the years 2015-2020 and statistical analysis of the coded data.

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients who received TLIF at the age of 55 years or older at the University Hospital Basel between 01.01.2015 and 1.07.2020.

You may qualify if:

• Indications for TLIF surgery (e.g., degenerative disc disease, spondylolisthesis)
• Existing preoperative upright standing sagittal plane X-ray of lumbar spine with clear visibility of pelvis, sacrum and femoral head
• Existing preoperative MRI of the lumbar region with clear visibility of different fatty infiltration grade and stenosis degree
• Complete follow-up at 3 months and 1 year postoperatively, including clinical and radiographic data

You may not qualify if:

• Neuromuscular diseases such as Parkinson's disease or multiple sclerosis according to our records
• Preoperative infection and/or malignancy tumor with involvement of the bony or soft tissue structures of the lumbar spine
• Presence of a documented consent dissent

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel, Orthopedics and Traumatology

Basel, 4031, Switzerland

Location

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Cordula Netzer, PD Dr. med.

  University Hospital Basel, Clinic for Orthopedics and Traumatology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 4, 2022
• Study Start: January 19, 2022
• Primary Completion: May 5, 2022
• Study Completion: February 15, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

CH (1)