Assessing Risk Factors for Radiological Complications After Transforaminal Lumbar Interbody Fusion

NCT ID: NCT05266638

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-19

Study Completion Date

2023-02-15

Brief Summary

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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

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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.

Conditions

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Degenerative Lumbar Spine Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Data 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cordula Netzer, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Basel, Clinic for Orthopedics and Traumatology

Locations

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University Hospital Basel, Orthopedics and Traumatology

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2021-02227; mu22Netzer

Identifier Type: -

Identifier Source: org_study_id

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