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Clinical Trials/NCT05266638
NCT05266638
Completed
Not Applicable

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

University Hospital, Basel, Switzerland1 site in 1 country170 target enrollmentJanuary 19, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Degenerative Lumbar Spine Diseases
Sponsor
University Hospital, Basel, Switzerland
Enrollment
170
Locations
1
Primary Endpoint
Number of Implant failure
Status
Completed
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 19, 2022
End Date
February 15, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Basel, Switzerland
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Number of patients needing revision surgery

Time Frame: one time assessment at baseline

Number of patients needing revision surgery, in relationship to age

Study Sites (1)

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