Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2025-05-22
2027-08-31
Brief Summary
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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.
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Detailed Description
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Patients will undergone an additional dynamic radiography 3 months after surgery to assess their spinal stability.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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postoperative dynamic radiography
all patients will perform a dynamic radiography 3 months after surgery
Postoperative dynamic radiography
Participants will perform a dynamic radiography 3 months after lumbar decompression surgery under UBE to study vertebral instability
Interventions
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Postoperative dynamic radiography
Participants will perform a dynamic radiography 3 months after lumbar decompression surgery under UBE to study vertebral instability
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Patient with history of lumbar arthrodesis,
* Patient not available for study follow-up.
50 Years
ALL
No
Sponsors
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Clinique Saint Jean, France
OTHER
Responsible Party
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Guillaume LONJON
Principal Investigator
Locations
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Clinique St Jean Sud de France
Montpellier, , France
Countries
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Central Contacts
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Facility Contacts
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Cécile SPIRITO
Role: backup
Other Identifiers
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2025-A00134-45
Identifier Type: -
Identifier Source: org_study_id
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