Spine DegenerationNCT06719349
Lumbar Discopathy Decompression with Lateral Interbody Fusion: Radiological and Clinical Outcomes
An observational study of Spine Degeneration and Fusion of Spine (Disease), run by Podkarpackie Oncological Center at 1 site in Poland.
Trial summary
The aim of the study was to introduce a single-segment lumbar spine decompression and fusion with intervertebral implants through modified by the authors lateral lumbar approach. Functional, surgical and radiographic outcomes was evaluated. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spine Degeneration, Fusion of Spine (Disease)
- How many people
- 38 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2021to 31 Dec 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We retrospectively reviewed the medical data of patients who underwent single-level LIF from January to December 2021 at the Orthopaedic Oncology Department in Brzozów and the Trauma and Orthopaedic Department in Stalowa Wola.
Who may be able to join
- Single-segment L1-L4 spine discopathy.
Who cannot join
- Any other spinal diseases. More than one level of discopathy.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Subcarpatian Oncology Centre
Brzozów, Podkarpackie Voivodeship, 38-500
About this study
Official title: Single-Level Lateral Lumbar Interbody Fusion in Author's Modification: Clinical and Radiographic Outcomes
The aim of the study was to introduce a single-segment lumbar spine decompression and fusion with intervertebral implants through modified by the authors lateral lumbar approach. Functional, surgical and radiographic outcomes was evaluated.
- Conditions
- Spine Degeneration, Fusion of Spine (Disease)
- Keywords
- Spine, Decompression, Interbody Fusion, Diskectomy
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single level decompression and LLIF | Patients with single-segment L1-L4 spine discopathy treated with lumbar spine fusion modified by the authors were included in this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
the quality of life
the quality of life according to the EQ-VAS - Euro-Quality of Life Visual Analoque Score
Measured: 3 months after the surgery
the functional status - Karnofsky scale
patients' neurological status, functional status according to the Karnofsky scale
Measured: 3 months after the surgery
the functional status Oswestry Disability Index
patients' neurological status, functional status according to the ODI - Oswestry Disability Index
Measured: 3 months after the surgery
the intensity of pain
the intensity of pain according to the VAS - Visual AnalogueScale score
Measured: 3 months after the surgery
Secondary outcomes (3)
Radiographic Outcomes: The Cross-Sectional Area of the Spinal Canal
Based on pre- and postoperative MRI/RTG the following aspects were assessed: The Cross-Sectional Area of the Spinal Canal, the width and depth of disc extrusion, and the width of the lateral recesses of the spinal canal, anterior disc height lumbar lordosis angle and lumbar segmental angle.
Measured: 3 months after the surgery
Radiographic Outcomes: The Height and Width of the Intervertebral Foramina
Based on pre- and postoperative MRI/RTG the following aspects were assessed: The Height and Width of the Intervertebral Foramina
Measured: 3 months after the surgery
Radiographic Outcomes: lumbar segmental angle.
Based on pre- and postoperative MRI/RTG the following aspects were assessed: lumbar segmental angle.
Measured: 3 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Jan 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spine DegenerationStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Podkarpackie Oncological Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grzegorz Guzik, Podkarpackie Oncological Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719349
- Sponsor's protocol ID
- 02-2024
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The medical records of the patients who participated in the study cannot be shared based on the protection of natural persons with regard to the processing of personal data according to the guidelines of the European Data Protection Board.
Publications
Schizas C, Theumann N, Burn A, Tansey R, Wardlaw D, Smith FW, Kulik G. Qualitative grading of severity of lumbar spinal stenosis based on the morphology of the dural sac on magnetic resonance images. Spine (Phila Pa 1976). 2010 Oct 1;35(21):1919-24. doi: 10.1097/BRS.0b013e3181d359bd.
PubMed 20671589Lin GX, Akbary K, Kotheeranurak V, Quillo-Olvera J, Jo HJ, Yang XW, Mahatthanatrakul A, Kim JS. Clinical and Radiologic Outcomes of Direct Versus Indirect Decompression with Lumbar Interbody Fusion: A Matched-Pair Comparison Analysis. World Neurosurg. 2018 Nov;119:e898-e909. doi: 10.1016/j.wneu.2018.08.003. Epub 2018 Aug 10.
PubMed 30099187Ozgur BM, Aryan HE, Pimenta L, Taylor WR. Extreme Lateral Interbody Fusion (XLIF): a novel surgical technique for anterior lumbar interbody fusion. Spine J. 2006 Jul-Aug;6(4):435-43. doi: 10.1016/j.spinee.2005.08.012.
PubMed 16825052
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Level Lateral Lumbar Interbody Fusion in Author's Modification: Clinical and Radiographic Outcomes
- ClinicalTrials.gov ID
- NCT06719349
- Acronym / sponsor ID
- 02-2024
- Conditions
- Spine Degeneration, Fusion of Spine (Disease)
- Keywords
- Spine, Decompression, Interbody Fusion, Diskectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Podkarpackie Oncological CenterUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 5 Dec 2024 (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.
The aim of the study was to introduce a single-segment lumbar spine decompression and fusion with intervertebral implants through modified by the authors lateral lumbar approach. Functional, surgical and radiographic outcomes was evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single level decompression and LLIF | – | –Patients with single-segment L1-L4 spine discopathy treated with lumbar spine fusion modified by the authors were included in this study |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We retrospectively reviewed the medical data of patients who underwent single-level LIF from January to December 2021 at the Orthopaedic Oncology Department in Brzozów and the Trauma and Orthopaedic Department in Stalowa Wola.
Key inclusion criteria (1 listed)
- Single-segment L1-L4 spine discopathy.
Key exclusion criteria (1 listed)
- Any other spinal diseases. More than one level of discopathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the quality of life
Time frame: 3 months after the surgery
the quality of life according to the EQ-VAS - Euro-Quality of Life Visual Analoque Score
the functional status - Karnofsky scale
Time frame: 3 months after the surgery
patients' neurological status, functional status according to the Karnofsky scale
the functional status Oswestry Disability Index
Time frame: 3 months after the surgery
patients' neurological status, functional status according to the ODI - Oswestry Disability Index
the intensity of pain
Time frame: 3 months after the surgery
the intensity of pain according to the VAS - Visual AnalogueScale score
3 secondary outcomes
Radiographic Outcomes: The Cross-Sectional Area of the Spinal Canal
Time frame: 3 months after the surgery
Radiographic Outcomes: The Height and Width of the Intervertebral Foramina
Time frame: 3 months after the surgery
Radiographic Outcomes: lumbar segmental angle.
Time frame: 3 months after the 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 5 Dec 2024.
- Background: PubMed 20671589Schizas C, Theumann N, Burn A, Tansey R, Wardlaw D, Smith FW, Kulik G. Qualitative grading of severity of lumbar spinal stenosis based on the morphology of the dural sac on magnetic resonance images. Spine (Phila Pa 1976). 2010 Oct 1;35(21):1919-24. doi: 10.1097/BRS.0b013e3181d359bd.
- Background: PubMed 30099187Lin GX, Akbary K, Kotheeranurak V, Quillo-Olvera J, Jo HJ, Yang XW, Mahatthanatrakul A, Kim JS. Clinical and Radiologic Outcomes of Direct Versus Indirect Decompression with Lumbar Interbody Fusion: A Matched-Pair Comparison Analysis. World Neurosurg. 2018 Nov;119:e898-e909. doi: 10.1016/j.wneu.2018.08.003. Epub 2018 Aug 10.
- Background: PubMed 16825052Ozgur BM, Aryan HE, Pimenta L, Taylor WR. Extreme Lateral Interbody Fusion (XLIF): a novel surgical technique for anterior lumbar interbody fusion. Spine J. 2006 Jul-Aug;6(4):435-43. doi: 10.1016/j.spinee.2005.08.012.
- Individual participant dataSharing planned: Undecided. The medical records of the patients who participated in the study cannot be shared based on the protection of natural persons with regard to the processing of personal data according to the guidelines of the European Data Protection Board.
Related trials for Spine Degeneration
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Recruiting
The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions
Lumbar Spine Degeneration, Lumbar Spine Instability
Recruiting
FIBERGRAFT Aeridyan Posterolateral Fusion Study
Degenerative Spine Disease
RecruitingObservational study
OssDsign® Spine Registry Study ("Propel")
Degenerative Disc Disease, Spinal Stenosis
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 Spine Degeneration and Fusion of Spine (Disease), run by Podkarpackie Oncological Center at 1 site in Poland.
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 1 inclusion and 1 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 5 Dec 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 Poland. 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?
the quality of life (time frame: 3 months after the surgery). The study lists 4 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 NCT06719349, which also lists 3 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 5 Dec 2024.