NCT06904326

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress44%
May 2025Aug 2027

First Submitted

Initial submission to the registry

March 31, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 1, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

May 22, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

2.2 years

First QC Date

March 31, 2025

Last Update Submit

November 21, 2025

Conditions

Spinal Instability

Keywords

biportal endoscopylumbar surgery

Outcome Measures

Primary Outcomes (1)

  • Spinal stability rate

    absence of abnormal vertebral mobility

    3 months

Secondary Outcomes (5)

  • Spondylolisthesis rate

    3 months

  • Perioperative complications rate

    1 day

  • Oswestry Disability index evaluation

    3 months

  • Pain evaluation

    3 months

  • Vertebral mobility evaluation

    3 months

Study Arms (1)

postoperative dynamic radiography

EXPERIMENTAL

all patients will perform a dynamic radiography 3 months after surgery

Other: Postoperative dynamic radiography

Interventions

Postoperative dynamic radiographyOTHER

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

postoperative dynamic radiography

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique St Jean Sud de France

Montpellier, France

RECRUITING

Central Study Contacts

Guillaume Lonjon, Dr

CONTACT

(0)467413453guilonjon@gmail.com

Marion MAYNADIER

CONTACT

(0)467413453marionmaynadier.recherche@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 31, 2025

First Posted

April 1, 2025

Study Start

May 22, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

November 26, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)