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NCT Number: NCT06904326

CLUBE (UBE Stability / Dynamic Radio)

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.

Recruiting

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Key information

Conditions

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique St Jean Sud de France

Montpellier, France

Location status: Recruiting

Location contact

Alexandre Dhenin

SUB_INVESTIGATOR

Cecile Spirito

CONTACT

[email protected]

+33467413399

Cécile SPIRITO

CONTACT

+33467413399

Guillaume Lonjon

PRINCIPAL_INVESTIGATOR

Matthieu VASSAL

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Postoperative dynamic radiography

Other

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

Primary outcomes

  1. Spinal stability rate

    Time frame: 3 months

    absence of abnormal vertebral mobility

Secondary outcomes

  1. Spondylolisthesis rate

    Time frame: 3 months

  2. Perioperative complications rate

    Time frame: 1 day

  3. Oswestry Disability index evaluation

    Time frame: 3 months

    measure of patient incapacity improvement after surgery

  4. Pain evaluation

    Time frame: 3 months

    measure of lumbar and radicular pain improvement after surgery with visual analog scale

  5. Vertebral mobility evaluation

    Time frame: 3 months

    change in vertebral mobility between preoperative and postoperative dynamic radiography

Study contacts

Contact information is provided by the study sponsor or research team.

Guillaume Lonjon, Dr

CONTACT

[email protected]

(0)467413453 ext. +33

Marion MAYNADIER

CONTACT

[email protected]

(0)467413453 ext. +33

Sponsors and collaborators

Lead sponsor

Clinique Saint Jean, France

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 1, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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