Clinical trial NCT05266638: Assessing Risk Factors for Radiological Complications After Transforaminal Lumbar Interbody Fusion
Official title: AgeTLIF - Assessing Risk Factors for Radiological Complications After Transforaminal Lumbar Interbody Fusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Lumbar Spine Diseases
Keywords: Posterior Lumbar Interbody Fusion (PLIF)
Transforaminal Lumbar Interbody Fusion (TLIF)
Implant Failure
Revision Surgery
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 170
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Number of Implant failure
timeFrame: one time assessment at baseline
measure: Number of patients needing revision surgery
timeFrame: one time assessment at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Orthopedics and Traumatology
Study officials:
affiliation: University Hospital Basel, Clinic for Orthopedics and Traumatology
name: Cordula Netzer, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: