CClinicalTrials.gg
CompletedNCT05266638AgeTLIFUpdated Feb 20, 2024

Assessing Risk Factors for Radiological Complications After Transforaminal Lumbar Interbody Fusion

An observational study in Degenerative Lumbar Spine Diseases, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2024-02-20.

Sponsored by University Hospital, Basel, Switzerland · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
170
Ages
55 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Degenerative Lumbar Spine Diseases

Browse trials for

Keywords

  • Posterior Lumbar Interbody Fusion (PLIF)
  • Transforaminal Lumbar Interbody Fusion (TLIF)
  • Implant Failure
  • Revision Surgery
03

In context

Spinal Diseases

267 studies on the registry are indexed under Spinal Diseases; 54 are open to participants now.

This study's enrollment of 170 is above the median of 108 across 87 observational studies indexed under Spinal Diseases.

Browse Spinal Diseases studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
170 participants (actual)
Patient registry
No

Interventions

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

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: one time assessment at baseline

  2. Number of patients needing revision surgery

    Number of patients needing revision surgery, in relationship to age

    Time frame: one time assessment at baseline

07

Study locations

1 site
  • University Hospital Basel, Orthopedics and Traumatology
    Basel, 4031, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05266638
Lead sponsor
University Hospital, Basel, Switzerland
Responsible party
Sponsor
First posted
Mar 4, 2022
Start date
Jan 19, 2022
Primary completion
May 5, 2022
Completion
Feb 15, 2023
Last update
Feb 20, 2024

Study contacts

Cordula Netzer, PD Dr. med.
principal investigator · University Hospital Basel, Clinic for Orthopedics and Traumatology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion