AzTrials
AzTrials

Lumbar DecompressionAGESNCT06523426

Ambulatory Geriatric Endoscopic Spine

An observational study of Lumbar Decompression, run by University Hospital, Bordeaux at 4 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The research focuses on evaluating the clinical outcomes of endoscopic lumbar decompression surgery performed in an outpatient setting for patients over 75 years old. This prospective, multicentric, non-interventional study aims to assess the feasibility and effectiveness of endoscopic techniques, specifically… Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Lumbar Decompression
What is being tested?
Patient treated by spinal endoscopy
How many people
50 participants
Where
4 sitesFrance
Study dates
18 Sep 2024to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Patient for whom an indication for ambulatory endoscopic surgery

Who may be able to join

  • Patient aged over 75 years.
  • Patient consulting for a medical condition involving a spinal pathology at the center, for which endoscopic lumbar decompression on one level is indicated.

Who cannot join

  • Patients under guardianship or trusteeship.
  • Individuals deprived of liberty by judicial or administrative decision.
  • Individuals undergoing psychiatric treatment under constraint requiring consent from a legal representative.
  • Individuals admitted to a health or social institution for purposes other than research.
  • Individuals unable to give consent.
  • Individuals under legal protection.
  • Patients not affiliated with a social security system.
  • Patients suffering from infectious, traumatic, or tumoral spinal pathology.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Benjamin BOUYER, PROF contact

+335 56 79 87 18

b.bouyer@chu-bordeaux.fr

Sébastien RODRIGUES-FERREIRA contact

sebastien.rodrigues-ferreira@chu-bordeaux.fr

France4 sites, 4 recruiting
  • CHU DE Bordeaux

    Bordeaux

    Benjamin BOUYER, PROF, +335 56 79 87 18, b.bouyer@chu-bordeaux.fr

    Recruiting
  • Cliniques Terrefort Bordeaux-Bruges

    Bruges, 33520

    Nicolas PELLET, MD, +335 35 54 41 41, dr.pellet@cliniquesterrefort.fr

    Not yet recruiting
  • Clinique Saint Jean - Sud de France

    Saint-Jean-de-Védas, 24430

    Guillaume LONJON, MD, +334 67 41 34 53, guilonjon@gmail.com

    Not yet recruiting
  • Clinique Saint Jean - Sud de France

    Saint-Jean-de-Védas, 24430

    Alexandre DHENIN, MD, +334 67 41 34 53, adhenin13@gmail.com

    Not yet recruiting

Other trials in France

About this study

Official title: Evaluation of Ambulatory Endoscopic Spinal Surgery in the Geriatric Population

The research focuses on evaluating the clinical outcomes of endoscopic lumbar decompression surgery performed in an outpatient setting for patients over 75 years old. This prospective, multicentric, non-interventional study aims to assess the feasibility and effectiveness of endoscopic techniques, specifically biportal and uniportal approaches, in reducing operative morbidity and hospital stay duration within this demographic. The primary objective is to determine the success rate of outpatient treatment using these endoscopic procedures in elderly patients

Read the detailed description

This study investigates the clinical outcomes of endoscopic lumbar decompression surgery performed in an outpatient setting for patients over 75 years old. Given the increasing prevalence of spinal pathologies in aging populations, traditional surgical approaches pose significant morbidity and extended hospital stays, especially for the elderly. Recent advancements in less invasive endoscopic techniques offer promising alternatives that may reduce these risks. This prospective, multicentric, non-interventional study aims to evaluate the feasibility and effectiveness of endoscopic lumbar decompression, specifically biportal and uniportal approaches, in reducing operative morbidity and hospital stay duration within this demographic.

Scientific Justification Spinal pathologies, particularly degenerative conditions of the lumbar spine, are common and lead to significant healthcare costs. With the aging population in developed countries, the incidence of these pathologies is increasing, with 100% of individuals over 60 years old showing structural degenerative changes and 60% experiencing related symptoms. Current surgical treatments, such as conventional lumbar decompression, often result in prolonged hospital stays and high morbidity, particularly among the elderly who typically present with multiple comorbidities, increased bone fragility, and functional limitations. Endoscopic surgery, a less invasive alternative, has demonstrated excellent outcomes in recent studies, including lower complication rates and shorter recovery times. However, its effectiveness in the outpatient setting for the geriatric population remains unstudied.

Treatment/Strategy/Procedure The study involves endoscopic lumbar decompression surgery, utilizing either biportal or uniportal techniques, performed on patients over 75 years old in an outpatient setting. This approach aims to minimize surgical trauma and preserve the physiological function and stability of the lumbar spine.

Follow-Up Patients will be followed for three months post-surgery to monitor clinical improvements and identify any peri- or post-operative complications. Data collected will include clinical examinations, quality of life assessments, medical history, ongoing treatments, and responses to self-administered questionnaires. The follow-up visit at three months will gather comprehensive information on patient progress, including clinical examinations, imaging data, therapeutic interventions, and medication use.

Being tested
Patient treated by spinal endoscopy
Keywords
outpatient surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient treated by spinal endoscopyDiagnostic test

    Questionnaire administered by surgeon; assessment of level of autonomy for activities of daily living

Study groups in NCT06523426
Study groupRoleWhat they receive
Patient treated by spinal endoscopyelderly patients, over 75 years old, treated by spinal endoscopy
Receives: Diagnostic Test: Patient treated by spinal endoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Success of outpatient care : Number of patient with convention hospitalization or readmission after endoscopic surgery

    The success of ambulatory management is the number of patients for whom an indication for endoscopic surgery is given and performed without the need for conventional hospitalization secondary to surgery, or readmission within 30 days of surgery

    Measured: 3 months visit

Secondary outcomes (10)
  1. Evaluation of Treatment Efficacy

    Evolution of perceived health scores specific to the treated pathology. ODI (Oswestry Disability Index) is a self-questionnaire with 10 items. Each question is rated from 0 to 5 and total score that varies from 0 to 50

    Measured: Inclusion visit, 3 months visit

  2. Evaluation of Treatment Safety

    Number of serious medical complications

    Measured: Inclusion visit, 3 months visit

  3. Evaluation of Treatment Safety

    Number of surgical site infections.

    Measured: Inclusion visit, 3 months visit

  4. Evaluation of Treatment Safety

    Number of mechanical complications.

    Measured: Inclusion visit, 3 months visit

  5. Evaluation of Treatment Safety

    Number of neurological complications.

    Measured: Inclusion visit, 3 months visit

  6. Evaluation of Treatment Safety

    Number of surgical re-interventions.

    Measured: Inclusion visit, 3 months visit

  7. Evaluation of Treatment Efficacy

    Evaluation of quality of life by self-questionnaire EQ-5D-5L

    Measured: Inclusion visit, 3 months visit

  8. Evaluation of Treatment Efficacy

    Evaluation of geriatric autonomy by IADL.

    Measured: Inclusion visit, 3 months visit

  9. Evaluation of Treatment Efficacy

    Evaluation of quality of life by self-questionnaire ODI

    Measured: Inclusion visit, 3 months visit

  10. Evaluation of Treatment Efficacy

    Evaluation of quality of life by self-questionnaire SF-36

    Measured: Inclusion visit, 3 months visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2024
  2. Study start18 Sep 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06523426
Sponsor's protocol ID
CHUBX 2023/92
Acronym
AGES
Status last verified
Nov 2024
First submitted
9 Jul 2024
Last updated
18 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lumbar Decompression, run by University Hospital, Bordeaux at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Benjamin BOUYER, PROF (+335 56 79 87 18, b.bouyer@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success of outpatient care : Number of patient with convention hospitalization or readmission after endoscopic surgery (time frame: 3 months visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in