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OpenTrials
Completed

NCT Number: NCT05266638

Assessing Risk Factors for Radiological Complications After Transforaminal Lumbar Interbody Fusion

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel, Orthopedics and Traumatology

Basel, 4031, Switzerland

About this study

Spinal fusion is one of the most commonly performed surgical procedures for the treatment of degenerative spinal disease. Interbody fusion with cages reconstructs the anterior column through disc removal, allowing to maintain proper disc height despite weight bearing, while providing firm fixation of the spinal segments. Transforaminal lumbar interbody fusion (TLIF) has fewer complications and less intraoperative bleeding than posterior lumbar interbody fusion (PLIF). Elderly patients are at high risk for perioperative and postoperative complications after lumbar fusion. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Number of Implant failure

    Time frame: one time assessment at baseline

    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

  2. Number of patients needing revision surgery

    Time frame: one time assessment at baseline

    Number of patients needing revision surgery, in relationship to age

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

AgeTLIF - Assessing Risk Factors for Radiological Complications After Transforaminal Lumbar Interbody Fusion

Acronym: AgeTLIF

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Mar 4, 2022
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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