Assessing Risk Factors for Radiological Complications After Transforaminal Lumbar Interbody Fusion

Completed

• Conditions: Degenerative Lumbar Spine Diseases

• Registration Number: NCT05266638
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study Start: 2022-01-19
• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-02-23
• Study First Posted: 2022-03-04
• Primary Completion: 2022-05-05
• Study Completion: 2023-02-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Implant failure	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	one time assessment at baseline	Number of patients needing revision surgery, in relationship to age

Trial Locations

Locations (1)

University Hospital Basel, Orthopedics and Traumatology; 🇨🇭 Basel, Switzerland