Spinal InstabilityNCT06904326
CLUBE (UBE Stability / Dynamic Radio)
A study testing Postoperative dynamic radiography in people with Spinal Instability, run by Clinique Saint Jean, France at 1 site in France.
Trial summary
Degenerative pathologies of the spine affect a large proportion of the increasingly ageing population, and are a major public health issue. When conservative treatments (physiotherapy, analgesics, infiltrations) fail, surgical treatment is preferred. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Spinal Instability
- What is being tested?
- Postoperative dynamic radiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 22 May 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient ≥ 50 ans,
- Patient requiring single-level or 2-levels lumbar decompression surgery under UBE,
- Patients who underwent dynamic radiography within 3 months prior to surgery,
- Patient who received information on the study and who signed the consent form.
Who cannot join
- Presence of a mobile spondylolisthesis with a ≥ 3 mm difference between flexion and extension movements on preoperative dynamic radiography,
- Patient with history of lumbar arthrodesis,
- Patient not available for study follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique St Jean Sud de France
Montpellier
Cecile Spirito, +33467413399, cecile.spirito@capsante.fr
Cécile SPIRITO, +33467413399
About this study
Official title: Assessment of Spinal Stability by Dynamic Radiography After Unilateral Biportal Endoscopic Lumbar Decompression Surgery
Degenerative pathologies of the spine affect a large proportion of the increasingly ageing population, and are a major public health issue. When conservative treatments (physiotherapy, analgesics, infiltrations) fail, surgical treatment is preferred.
Traditionally, a simple lumbar recalibration operation is preferred (bilateral laminectomy decompression), but this may affect spinal stability. In cases of spondylolisthesis or preoperative instability, lumbar fusion (arthrodesis) is sometimes necessary to avoid the risk of major instability, but such an operation is not without risk and may require repeat surgery.
Read more
The development of new surgical techniques such as uni or bilateral laminotomies, which are less radical, has made it possible to avoid some arthrodeses. Nowadays, the emergence of new surgical techniques such as endoscopy has further reduced the risk of destabilization (shorter post-operative convalescence, less atrophy of the paraspinal muscles) and improved surgeon comfort (better vision and easier instrument handling).
Unilateral biportal endoscopy (UBE) is one of two endoscopic techniques and has proven its effectiveness for lumbar decompression in terms of clinical benefits. However, there is no scientific evidence on spinal stability after recalibration under UBE.
We believe that minimizing invasiveness with UBE during simple lumbar recalibration surgery can preserve spinal stability, thereby reducing the need for lumbar fixation and lowering the cost of care.
We therefore propose to study the maintenance of spinal stability using dynamic radiography at 3 months post-operatively in patients undergoing lumbar recalibration surgery with UBE.
Read the detailed description
Spinal stability is defined by the absence of abnormal mobility (sagittal translation of at least 3 mm) between flexion and extension movements and will be assessed on the 3-months postoperative dynamic radiography.
Patients will undergone an additional dynamic radiography 3 months after surgery to assess their spinal stability.
- Conditions
- Spinal Instability
- Being tested
- Postoperative dynamic radiography
- Keywords
- biportal endoscopy, lumbar surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative dynamic radiographyOther
Participants will perform a dynamic radiography 3 months after lumbar decompression surgery under UBE to study vertebral instability
| Study group | Role | What they receive |
|---|---|---|
| postoperative dynamic radiography | Experimental | all patients will perform a dynamic radiography 3 months after surgery Receives: Other: Postoperative dynamic radiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal stability rate
absence of abnormal vertebral mobility
Measured: 3 months
Secondary outcomes (5)
Spondylolisthesis rate
Measured: 3 months
Perioperative complications rate
Measured: 1 day
Oswestry Disability index evaluation
measure of patient incapacity improvement after surgery
Measured: 3 months
Pain evaluation
measure of lumbar and radicular pain improvement after surgery with visual analog scale
Measured: 3 months
Vertebral mobility evaluation
change in vertebral mobility between preoperative and postoperative dynamic radiography
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start22 May 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal InstabilityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Saint Jean, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillaume LONJON, Clinique Saint Jean, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904326
- Sponsor's protocol ID
- 2025-A00134-45
- Status last verified
- Nov 2025
- First submitted
- 31 Mar 2025
- Last updated
- 26 Nov 2025
- 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 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Spinal Stability by Dynamic Radiography After Unilateral Biportal Endoscopic Lumbar Decompression Surgery
- ClinicalTrials.gov ID
- NCT06904326
- Acronym / sponsor ID
- 2025-A00134-45
- Conditions
- Spinal Instability
- Keywords
- biportal endoscopy, lumbar surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Clinique Saint Jean, FranceUniversity, hospital or other
- Study start
- 22 May 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 1 Apr 2025 (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.
Degenerative pathologies of the spine affect a large proportion of the increasingly ageing population, and are a major public health issue. When conservative treatments (physiotherapy, analgesics, infiltrations) fail, surgical treatment is preferred.
Traditionally, a simple lumbar recalibration operation is preferred (bilateral laminectomy decompression), but this may affect spinal stability. In cases of spondylolisthesis or preoperative instability, lumbar fusion (arthrodesis) is sometimes necessary to avoid the risk of major instability, but such an operation is not without risk and may require repeat surgery.
The development of new surgical techniques such as uni or bilateral laminotomies, which are less radical, has made it possible to avoid some arthrodeses. Nowadays, the emergence of new surgical techniques such as endoscopy has further reduced the risk of destabilization (shorter post-operative convalescence, less atrophy of the paraspinal muscles) and improved surgeon comfort (better vision and easier instrument handling).
Unilateral biportal endoscopy (UBE) is one of two endoscopic techniques and has proven its effectiveness for lumbar decompression in terms of clinical benefits. However, there is no scientific evidence on spinal stability after recalibration under UBE.
We believe that minimizing invasiveness with UBE during simple lumbar recalibration surgery can preserve spinal stability, thereby reducing the need for lumbar fixation and lowering the cost of care.
We therefore propose to study the maintenance of spinal stability using dynamic radiography at 3 months post-operatively in patients undergoing lumbar recalibration surgery with UBE.
Detailed description
Spinal stability is defined by the absence of abnormal mobility (sagittal translation of at least 3 mm) between flexion and extension movements and will be assessed on the 3-months postoperative dynamic radiography.
Patients will undergone an additional dynamic radiography 3 months after surgery to assess their spinal stability.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| postoperative dynamic radiography | Experimental | Other: Postoperative dynamic radiographyall patients will perform a dynamic radiography 3 months after surgery |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient ≥ 50 ans,
- Patient requiring single-level or 2-levels lumbar decompression surgery under UBE,
- Patients who underwent dynamic radiography within 3 months prior to surgery,
- Patient who received information on the study and who signed the consent form.
Key exclusion criteria (3 listed)
- Presence of a mobile spondylolisthesis with a ≥ 3 mm difference between flexion and extension movements on preoperative dynamic radiography,
- Patient with history of lumbar arthrodesis,
- Patient not available for study follow-up.
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 |
|---|---|---|
| Postoperative dynamic radiographyParticipants will perform a dynamic radiography 3 months after lumbar decompression surgery under UBE to study vertebral instability | Other | postoperative dynamic radiography |
Primary outcome
Spinal stability rate
Time frame: 3 months
absence of abnormal vertebral mobility
5 secondary outcomes
Spondylolisthesis rate
Time frame: 3 months
Perioperative complications rate
Time frame: 1 day
Oswestry Disability index evaluation
Time frame: 3 months
Pain evaluation
Time frame: 3 months
Vertebral mobility evaluation
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative dynamic radiography in people with Spinal Instability, run by Clinique Saint Jean, France 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 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: looking for participants now, as of the sponsor's last update on 26 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Lonjon, Dr ((0)467413453 ext. +33, guilonjon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinal stability rate (time frame: 3 months). 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 26 Nov 2025; AzTrials last refreshed its copy on 28 Oct 2026.