Lumbar Disc HerniationNCT05246241
Preoperative Magnetic Resonance Imaging Abnormalities Predictive of Lumbar Herniation Recurrence
An observational study of Lumbar Disc Herniation, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
There are currently no standard criteria for evaluating the risk of recurrent disk herniation following surgical repair. This study investigated the predictive values of five presurgical imaging parameters, paraspinal muscle quality, annular tear size, Modic changes, modified Pfirrmann's disc degeneration grade, and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- magnetic resonance imaging
- Type of treatment
- Medical device
- How many people
- 188 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 1 Feb 2022
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 18-75 male and female single-level lumbar disk herniation
Who may be able to join
- first operation for a single-level lumbar disk herniation
- no concurrent spinal pathology such as stenosis, spondylolisthesis, or deformity
- complete data on clinical and radiological parameters
Who cannot join
- the operation was for multi-level pathologies
- recurrent surgery
- exhibited concurrent spinal pathology
- was missing or incomplete clinical and radiological data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Magnetic Resonance Imaging Abnormalities Predictive of Lumbar Herniation Recurrence Following Surgical Repair
There are currently no standard criteria for evaluating the risk of recurrent disk herniation following surgical repair. This study investigated the predictive values of five presurgical imaging parameters, paraspinal muscle quality, annular tear size, Modic changes, modified Pfirrmann's disc degeneration grade, and presence of sacralization or fusion.
Clinical status and MRI findings were evaluated before surgery and 4, 12, and 24 months post-surgery using a Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and Short Form 36 (SF36).
- Conditions
- Lumbar Disc Herniation
- Being tested
- magnetic resonance imaging
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imagingDevice
Preoperative magnetic resonance imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
Paraspinal muscle quality
Simplified 3-tier classification
Measured: Preoperative 1 month
Annular tear size
With computer as millimeter
Measured: Preoperative 1 month
Modic changes
Modic classification
Measured: Preoperative 1 month
Disc degeneration grade
modified Pfirrmann's classification
Measured: Preoperative 1 month
sacralization or fusion
MRI findings
Measured: Preoperative 1 month
Secondary outcomes (3)
Visual Analog Scale
0-10 numerical scale (0=no pain, 10 =the worst pain)
Measured: 4, 12, and 24 months after surgery
Oswestry Disability Index (ODI)
Oswestry Low Back Pain Disability Questionnaire
Measured: 4, 12, and 24 months after surgery
Short Form 36 (SF36)
SF-36 Questionnaire
Measured: 4, 12, and 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start1 Apr 2021
- Primary completion1 Nov 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe 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
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Kursat Karadag, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246241
- Sponsor's protocol ID
- ATANEUROSURGERY-1
- Status last verified
- Feb 2022
- First submitted
- 9 Feb 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ammerman J, Watters WC, Inzana JA, Carragee G, Groff MW. Closing the Treatment Gap for Lumbar Disc Herniation Patients with Large Annular Defects: A Systematic Review of Techniques and Outcomes in this High-risk Population. Cureus. 2019 May 7;11(5):e4613. doi: 10.7759/cureus.4613.
PubMed 31312540Parker SL, Mendenhall SK, Godil SS, Sivasubramanian P, Cahill K, Ziewacz J, McGirt MJ. Incidence of Low Back Pain After Lumbar Discectomy for Herniated Disc and Its Effect on Patient-reported Outcomes. Clin Orthop Relat Res. 2015 Jun;473(6):1988-99. doi: 10.1007/s11999-015-4193-1.
PubMed 25694267
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Magnetic Resonance Imaging Abnormalities Predictive of Lumbar Herniation Recurrence Following Surgical Repair
- ClinicalTrials.gov ID
- NCT05246241
- Acronym / sponsor ID
- ATANEUROSURGERY-1
- Conditions
- Lumbar Disc Herniation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 18 Feb 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.
There are currently no standard criteria for evaluating the risk of recurrent disk herniation following surgical repair. This study investigated the predictive values of five presurgical imaging parameters, paraspinal muscle quality, annular tear size, Modic changes, modified Pfirrmann's disc degeneration grade, and presence of sacralization or fusion.
Clinical status and MRI findings were evaluated before surgery and 4, 12, and 24 months post-surgery using a Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and Short Form 36 (SF36).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18-75 male and female single-level lumbar disk herniation
Key inclusion criteria (3 listed)
- first operation for a single-level lumbar disk herniation
- no concurrent spinal pathology such as stenosis, spondylolisthesis, or deformity
- complete data on clinical and radiological parameters
Key exclusion criteria (4 listed)
- the operation was for multi-level pathologies
- recurrent surgery
- exhibited concurrent spinal pathology
- was missing or incomplete clinical and radiological data
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 |
|---|---|---|
| magnetic resonance imagingPreoperative magnetic resonance imaging | Device | – |
Primary outcome
Paraspinal muscle quality
Time frame: Preoperative 1 month
Simplified 3-tier classification
Annular tear size
Time frame: Preoperative 1 month
With computer as millimeter
Modic changes
Time frame: Preoperative 1 month
Modic classification
Disc degeneration grade
Time frame: Preoperative 1 month
modified Pfirrmann's classification
sacralization or fusion
Time frame: Preoperative 1 month
MRI findings
3 secondary outcomes
Visual Analog Scale
Time frame: 4, 12, and 24 months after surgery
Oswestry Disability Index (ODI)
Time frame: 4, 12, and 24 months after surgery
Short Form 36 (SF36)
Time frame: 4, 12, and 24 months after surgery
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 8 Mar 2022.
- Background: PubMed 31312540Ammerman J, Watters WC, Inzana JA, Carragee G, Groff MW. Closing the Treatment Gap for Lumbar Disc Herniation Patients with Large Annular Defects: A Systematic Review of Techniques and Outcomes in this High-risk Population. Cureus. 2019 May 7;11(5):e4613. doi: 10.7759/cureus.4613.
- Background: PubMed 25694267Parker SL, Mendenhall SK, Godil SS, Sivasubramanian P, Cahill K, Ziewacz J, McGirt MJ. Incidence of Low Back Pain After Lumbar Discectomy for Herniated Disc and Its Effect on Patient-reported Outcomes. Clin Orthop Relat Res. 2015 Jun;473(6):1988-99. doi: 10.1007/s11999-015-4193-1.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lumbar Disc Herniation, run by Ataturk University at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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 8 Mar 2022. 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 Turkey (Türkiye). 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?
Paraspinal muscle quality (time frame: Preoperative 1 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05246241, which also lists 2 linked publications.
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 8 Mar 2022.