Disc HerniationUBEVALNCT06448416
Assessment of Unilateral Biportal Endoscopy Technique Applied to Treatment of Degenerative Lumbar Pathologies
An observational study of Disc Herniation, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Lumbar disc herniation (HDL) is one of the main causes for low back pain and sciatica. Although non surgical care remains the gold standard as first treatment, lumbar discectomy is used to effectively relieve symptoms that persist for prolonged periods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disc Herniation
- What is being tested?
- UBE
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2022to 31 Mar 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population means patients who fulfill inclusion and exclusion criteria
Who may be able to join
- Patient, male or female, over 18 years old
- Patient with lumbar disc herniation or non-instrumented degenerative lumbar pathology
- Patient operated with UBE technique
Who cannot join
- Patient with extreme lateral disc herniation.
- Patient suffering from other serious illnesses
- Patient with lumbar instability, lumbar infection or lumbar tumor,
- Patient with multi-segmental lumbar disease requiring treatment
Trial locations and contacts
1 site in 1 country.
About this study
Lumbar disc herniation (HDL) is one of the main causes for low back pain and sciatica. Although non surgical care remains the gold standard as first treatment, lumbar discectomy is used to effectively relieve symptoms that persist for prolonged periods.
With surgical techniques evolution, minimally invasive spine surgery has emerged in recent decades as an alternative to conventional open surgery and is widely used for HDL treatment. Several minimally invasive surgical endoscopic techniques have been developed for disc herniation: Single Portal Endoscopy (SE), Video Assisted Endoscopic Discectomy, and recently Unilateral Biportal Endoscopy (UBE).
Read more
Currently, SE is considered as the minimally invasive surgery gold standard for HDL but, over the past two years, UBE for the treatment of degenerative lumbar diseases has increased exponentially with faster learning curve than other endoscopic techniques.
As an emerging technique, further studies are needed to better understand UBE. This is why Dr. Cristini's team wish to analyze a cohort of patients for whom this technique has been used since July 2022, in particular the complication rate.
Controlling a new technique requires a learning phase. This is why Dr. Cristini's team also wishes to describe the learning curve on the cohort of patients for whom UBE was used since July 2022.
Read the detailed description
Lumbar disc herniation (HDL) is one of the main causes for low back pain and sciatica, affecting 1 to 5% of the population each year. Although non surgical care remains the gold standard as first treatment, lumbar discectomy is used to effectively relieve symptoms that persist for prolonged periods.
With surgical techniques evolution, minimally invasive spine surgery has emerged in recent decades as an alternative to conventional open surgery and is widely used for HDL treatment. Compared to traditional open surgery, minimally invasive surgical technique offers muscle and bone sparing, pain reduction and faster recovery, allowing patient management in Enhanced Recovery After Surgery (RAAC).
Several minimally invasive surgical endoscopic techniques have been developed for disc herniation: Single Portal Endoscopy (SE), Video Assisted Endoscopic Discectomy, and recently Unilateral Biportal Endoscopy (UBE). SE relies on a single entry route whereas UBE is based on two entry routes : one way for optical instruments and saline irrigation system and one way for surgical instruments. Currently, SE is considered as the minimally invasive surgery gold standard for HDL treatment thanks to its advantages for controlling muscles trauma, reducing hospital stay and maintaining spinal segment stability.
Over the past two years, UBE for the treatment of degenerative lumbar diseases has increased exponentially with faster learning curve than other endoscopic techniques.
UBE allows a wider field of vision, wide and ergonomic operating gestures, is minimally invasive and contributes to complete nervous decompression and faster recovery. With UBE, the surgeon can use one hand to guide endoscope and he other one to guide surgical instruments . In addition, UBE generates less trauma, less bleeding, rapid recovery and good effectiveness in HDL treatment . UBE can significantly reduce postoperative nerve fibrosis, and postoperative spinal instability incidence.
During UBE, some postoperative complications have been described as poor treatment effectiveness (nucleus pulposus nucleus residue), epidural hematoma, dural tear, nerve root injury and incomplete surgery.
As an emerging technique, further studies are needed to better understand UBE. This is why Dr. Cristini's team wish to analyze a cohort of patients for whom this technique has been used since July 2022, in particular the complication rate.
Controlling a new technique requires a learning phase. Chen, L et al. showed that the operation duration and the postoperative hospitalization duration, were reduced from the 24th patient until the 97th patient out of a cohort of 97 patients with lumbar disc herniation treated by UBE. However, there was no significant difference in the visual analogue scale (VAS) and the Oswestry disability index (ODI) in all operated patients. This indicates that UBE still guarantees clinical effect and safety on all operated patients. This is why Dr. Cristini's team also wishes to describe the learning curve on the cohort of patients for whom UBE was used since July 2022.
- Conditions
- Disc Herniation
- Being tested
- UBE
- 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.
UBEProcedure or surgery
Patients with HDL were treated with UBE
| Study group | Role | What they receive |
|---|---|---|
| Unilateral Biportal Endoscopy (UBE) Technique | Patient with LDH treated by UBE Receives: Procedure: UBE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient complication rate
Complications will include epidural hematoma, nerve root injury, neurological deficit, dural breach or tear, incomplete surgery, epileptic crisis, hypothermia. Other complications will be HDL recurrence, pain neuropathy, infection and thromboembolic complications
Measured: 2 days
Secondary outcomes (1)
surgeon learning curve
UBE learning curve will be assessed with surgery time (minutes)
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Jul 2022
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disc HerniationStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- 500 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448416
- Sponsor's protocol ID
- RGDS-2023-12-014
- Acronym
- UBEVAL
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Unilateral Biportal Endoscopy Technique Applied to Treatment of Degenerative Lumbar Pathologies
- ClinicalTrials.gov ID
- NCT06448416
- Acronym / sponsor ID
- UBEVAL / RGDS-2023-12-014
- Conditions
- Disc Herniation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 7 Jun 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.
Lumbar disc herniation (HDL) is one of the main causes for low back pain and sciatica. Although non surgical care remains the gold standard as first treatment, lumbar discectomy is used to effectively relieve symptoms that persist for prolonged periods.
With surgical techniques evolution, minimally invasive spine surgery has emerged in recent decades as an alternative to conventional open surgery and is widely used for HDL treatment. Several minimally invasive surgical endoscopic techniques have been developed for disc herniation: Single Portal Endoscopy (SE), Video Assisted Endoscopic Discectomy, and recently Unilateral Biportal Endoscopy (UBE).
Currently, SE is considered as the minimally invasive surgery gold standard for HDL but, over the past two years, UBE for the treatment of degenerative lumbar diseases has increased exponentially with faster learning curve than other endoscopic techniques.
As an emerging technique, further studies are needed to better understand UBE. This is why Dr. Cristini's team wish to analyze a cohort of patients for whom this technique has been used since July 2022, in particular the complication rate.
Controlling a new technique requires a learning phase. This is why Dr. Cristini's team also wishes to describe the learning curve on the cohort of patients for whom UBE was used since July 2022.
Detailed description
Lumbar disc herniation (HDL) is one of the main causes for low back pain and sciatica, affecting 1 to 5% of the population each year. Although non surgical care remains the gold standard as first treatment, lumbar discectomy is used to effectively relieve symptoms that persist for prolonged periods.
With surgical techniques evolution, minimally invasive spine surgery has emerged in recent decades as an alternative to conventional open surgery and is widely used for HDL treatment. Compared to traditional open surgery, minimally invasive surgical technique offers muscle and bone sparing, pain reduction and faster recovery, allowing patient management in Enhanced Recovery After Surgery (RAAC).
Several minimally invasive surgical endoscopic techniques have been developed for disc herniation: Single Portal Endoscopy (SE), Video Assisted Endoscopic Discectomy, and recently Unilateral Biportal Endoscopy (UBE). SE relies on a single entry route whereas UBE is based on two entry routes : one way for optical instruments and saline irrigation system and one way for surgical instruments. Currently, SE is considered as the minimally invasive surgery gold standard for HDL treatment thanks to its advantages for controlling muscles trauma, reducing hospital stay and maintaining spinal segment stability.
Over the past two years, UBE for the treatment of degenerative lumbar diseases has increased exponentially with faster learning curve than other endoscopic techniques.
UBE allows a wider field of vision, wide and ergonomic operating gestures, is minimally invasive and contributes to complete nervous decompression and faster recovery. With UBE, the surgeon can use one hand to guide endoscope and he other one to guide surgical instruments . In addition, UBE generates less trauma, less bleeding, rapid recovery and good effectiveness in HDL treatment . UBE can significantly reduce postoperative nerve fibrosis, and postoperative spinal instability incidence.
During UBE, some postoperative complications have been described as poor treatment effectiveness (nucleus pulposus nucleus residue), epidural hematoma, dural tear, nerve root injury and incomplete surgery.
As an emerging technique, further studies are needed to better understand UBE. This is why Dr. Cristini's team wish to analyze a cohort of patients for whom this technique has been used since July 2022, in particular the complication rate.
Controlling a new technique requires a learning phase. Chen, L et al. showed that the operation duration and the postoperative hospitalization duration, were reduced from the 24th patient until the 97th patient out of a cohort of 97 patients with lumbar disc herniation treated by UBE. However, there was no significant difference in the visual analogue scale (VAS) and the Oswestry disability index (ODI) in all operated patients. This indicates that UBE still guarantees clinical effect and safety on all operated patients. This is why Dr. Cristini's team also wishes to describe the learning curve on the cohort of patients for whom UBE was used since July 2022.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unilateral Biportal Endoscopy (UBE) Technique | – | Procedure: UBEPatient with LDH treated by UBE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population means patients who fulfill inclusion and exclusion criteria
Key inclusion criteria (3 listed)
- Patient, male or female, over 18 years old
- Patient with lumbar disc herniation or non-instrumented degenerative lumbar pathology
- Patient operated with UBE technique
Key exclusion criteria (4 listed)
- Patient with extreme lateral disc herniation.
- Patient suffering from other serious illnesses
- Patient with lumbar instability, lumbar infection or lumbar tumor,
- Patient with multi-segmental lumbar disease requiring treatment
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 |
|---|---|---|
| UBEPatients with HDL were treated with UBE | Procedure or surgery | Unilateral Biportal Endoscopy (UBE) Technique |
Primary outcome
Patient complication rate
Time frame: 2 days
Complications will include epidural hematoma, nerve root injury, neurological deficit, dural breach or tear, incomplete surgery, epileptic crisis, hypothermia. Other complications will be HDL recurrence, pain neuropathy, infection and thromboembolic complications
1 secondary outcome
surgeon learning curve
Time frame: 21 months
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 7 Jun 2024.
- Individual participant dataSharing planned: No
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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 Disc Herniation, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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 7 Jun 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 France. 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?
Patient complication rate (time frame: 2 days). 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 7 Jun 2024.