Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
NCT06904326

CLUBE (UBE Stability / Dynamic Radio)

Led by Clinique Saint Jean, France · Updated on 2025-11-26

400

Participants Needed

1

Research Sites

114 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

CLUBE (UBE Stability / Dynamic Radio)

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 50 years or older
  • Patients requiring single-level or two-level lumbar decompression surgery under unilateral biportal endoscopy (UBE)
  • Patients who had dynamic radiography within 3 months before surgery
  • Patients informed about the study and who signed the consent form
Not Eligible

You will not qualify if you...

  • Presence of mobile spondylolisthesis with 3 mm or more difference between flexion and extension on preoperative dynamic radiography
  • History of lumbar fusion surgery
  • Patients unavailable for follow-up during the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Clinique St Jean Sud de France

Montpellier, France

Actively Recruiting

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Research Team

G

Guillaume Lonjon, Dr

CONTACT

M

Marion MAYNADIER

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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