CLUBE (UBE Stability / Dynamic Radio)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Instability
• Intervention / Treatment: Other: Postoperative dynamic radiography

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 Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guillaume Lonjon, Dr; Phone Number: +33 (0)467413453; Email: guilonjon@gmail.com
• Study Contact Backup: Name: Marion MAYNADIER; Phone Number: +33 (0)467413453; Email: marionmaynadier.recherche@gmail.com

Study Locations

• France
  • Montpellier, France
    • Recruiting
    • Clinique St Jean Sud de France
    • Contact: Cecile Spirito; Phone Number: +33467413399; Email: cecile.spirito@capsante.fr
    • Contact: Cécile SPIRITO; Phone Number: +33467413399
    • Principal Investigator: Guillaume Lonjon
    • Sub-Investigator: Matthieu VASSAL
    • Sub-Investigator: Alexandre Dhenin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: postoperative dynamic radiography; all patients will perform a dynamic radiography 3 months after surgery	Other: Postoperative dynamic radiography; Participants will perform a dynamic radiography 3 months after lumbar decompression surgery under UBE to study vertebral instability

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spinal stability rate	absence of abnormal vertebral mobility	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spondylolisthesis rate		3 months
Perioperative complications rate		1 day
Oswestry Disability index evaluation	measure of patient incapacity improvement after surgery	3 months
Pain evaluation	measure of lumbar and radicular pain improvement after surgery with visual analog scale	3 months
Vertebral mobility evaluation	change in vertebral mobility between preoperative and postoperative dynamic radiography	3 months

Collaborators and Investigators

• Sponsor: Clinique Saint Jean, France

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: March 31, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: lumbar surgery; biportal endoscopy
• Other Study ID Numbers: 2025-A00134-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No