Degenerative Lumbar Spine DiseasesAgeTLIFNCT05266638
Assessing Risk Factors for Radiological Complications After Transforaminal Lumbar Interbody Fusion
An observational study of Degenerative Lumbar Spine Diseases, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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 more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Degenerative Lumbar Spine Diseases
- What is being tested?
- Data collection (radiological parameters, outcome information) from electronic patient files in hospital data system
- How many people
- 170 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 Jan 2022to 15 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Orthopedics and Traumatology
Basel, 4031
About this study
Official title: AgeTLIF - Assessing Risk Factors for Radiological Complications After Transforaminal Lumbar Interbody 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.
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.
- Conditions
- Degenerative Lumbar Spine Diseases
- Being tested
- Data collection (radiological parameters, outcome information) from electronic patient files in hospital data system
- Keywords
- Posterior Lumbar Interbody Fusion (PLIF), Transforaminal Lumbar Interbody Fusion (TLIF), Implant Failure, Revision Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection (radiological parameters, outcome information) from electronic patient files in hospital data systemOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one time assessment at baseline
Number of patients needing revision surgery
Number of patients needing revision surgery, in relationship to age
Measured: one time assessment at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start19 Jan 2022
- Primary completion5 May 2022
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Lumbar Spine DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cordula Netzer, PD Dr. med., Principal investigator, University Hospital Basel, Clinic for Orthopedics and Traumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266638
- Sponsor's protocol ID
- 2021-02227; mu22Netzer
- Acronym
- AgeTLIF
- Status last verified
- Feb 2024
- First submitted
- 23 Feb 2022
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AgeTLIF - Assessing Risk Factors for Radiological Complications After Transforaminal Lumbar Interbody Fusion
- ClinicalTrials.gov ID
- NCT05266638
- Acronym / sponsor ID
- AgeTLIF / 2021-02227; mu22Netzer
- Conditions
- Degenerative Lumbar Spine Diseases
- Keywords
- Posterior Lumbar Interbody Fusion (PLIF), Transforaminal Lumbar Interbody Fusion (TLIF), Implant Failure, Revision Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 5 May 2022 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 4 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collection (radiological parameters, outcome information) from electronic patient files in hospital data systemCollection 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. | Other | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cordula Netzer, PD Dr. med. principal investigator
University Hospital Basel, Clinic for Orthopedics and Traumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Lumbar Spine Diseases, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Implant failure (time frame: one time assessment at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.