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CLUBE (UBE Stability / Dynamic Radio)

Assessment of Spinal Stability by Dynamic Radiography After Unilateral Biportal Endoscopic Lumbar Decompression Surgery

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06904326
Enrollment
400
Registered
2025-04-01
Start date
2025-05-22
Completion date
2027-08-31
Last updated
2025-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Instability

Keywords

biportal endoscopy, lumbar surgery

Brief 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. 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.

Interventions

OTHERPostoperative dynamic radiography

Participants will perform a dynamic radiography 3 months after lumbar decompression surgery under UBE to study vertebral instability

Sponsors

Clinique Saint Jean, France
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Spinal stability rate3 monthsabsence of abnormal vertebral mobility

Secondary

MeasureTime frameDescription
Spondylolisthesis rate3 months
Perioperative complications rate1 day
Oswestry Disability index evaluation3 monthsmeasure of patient incapacity improvement after surgery
Pain evaluation3 monthsmeasure of lumbar and radicular pain improvement after surgery with visual analog scale
Vertebral mobility evaluation3 monthschange in vertebral mobility between preoperative and postoperative dynamic radiography

Countries

France

Contacts

Primary ContactGuillaume Lonjon, Dr
guilonjon@gmail.com(0)467413453
Backup ContactMarion MAYNADIER
marionmaynadier.recherche@gmail.com(0)467413453

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026