NCT05015036

Brief Summary

Prospective longitudinal multicentre observational study carried out on a population of patients undergoing minimally invasive spine surgery and divided into two parallel cohorts according to the presence or absence of a Enhanced Recovery After Surgery (ERAS) programme. The patient will be assessed during 4 visits: At inclusion before surgery, at D0 (day of surgery), at D1 (postoperative visit) and at M1 (follow-up visit).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

August 16, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

February 28, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2023

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

1.5 years

First QC Date

August 16, 2021

Last Update Submit

July 2, 2024

Conditions

Spine Surgery

Outcome Measures

Primary Outcomes (1)

  • Oswestry Disability Index improvement

    The Oswestry Disability Index (Appendix 1) (also known as the Oswestry Low Back Pain Disability) is the gold standard tool for assessing functional disability related to low back pain and functional recovery after surgery. It consists of ten questions rated from 0 to 5 (from most to least favourable). The result is expressed as a percentage according to the following formula \[score obtained / (maximum score)\] X 100. The maximum score is 50 if all the questions have been filled in, 45 if one question has not been filled in etc..... The disability rate, corresponding to the percentage, obtained is considered minimal between 0 and 20%, moderate between 21 and 40% and severe above 41%. Therapeutic success defined as an improvement ≥30% in the Oswestry Disability Index between initial and final visit is the primary endpoint

    Month 1

Secondary Outcomes (10)

  • Post-operative pain

    Day 1

  • Post-operative pain

    Month 1

  • Consumption of level I, II and II analgesics

    Day 1

  • Consumption of level I, II and II analgesics

    Month 1

  • Pain-free walking perimeter

    Month 1

  • +5 more secondary outcomes

Study Arms (2)

Minimally invasive surgery of the lumbar spine with ERAS

Minimally invasive surgery of the lumbar spine with Enhanced Recovery After Surgery (ERAS)

Procedure: ERAS

Minimally invasive surgery of the lumbar spine

Minimally invasive surgery of the lumbar spine

Procedure: Minimally invasive surgery

Interventions

ERASPROCEDURE

Minimally invasive surgery of the lumbar spine with Enhanced Recovery After Surgery (ERAS)

Minimally invasive surgery of the lumbar spine with ERAS
Minimally invasive surgeryPROCEDURE

Classic Minimally invasive surgery of the lumbar spine

Minimally invasive surgery of the lumbar spine

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patient population for minimally invasive lumbar spine surgery

You may qualify if:

  • Adult male or female (18 years or older)
  • Patient who has agreed to participate in the study and has read and signed the consent form for participation in the study
  • Patient for whom a minimally invasive spine surgery is planned: (dicectomy, lumbar canal recalibration with or without laminectomy, lumbar arthrodesis by posterior approach limited to one stage)

You may not qualify if:

  • Patient with a contraindication to spinal anaesthesia
  • A bedridden or institutionalised patient
  • Mental deficiency or any other reason that may hinder the understanding or the strict application of the protocol
  • Patient not affiliated to the French social security system
  • Patient under legal protection, guardianship or curatorship
  • Patient already included in another therapeutic study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Geoffroy Saint-Hilaire

Paris, 75005, France

Location

MeSH Terms

Interventions

Minimally Invasive Surgical Procedures

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Arthur ANDRE, MD

    Clinique Geoffroy Saint-Hilaire

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2021

First Posted

August 20, 2021

Study Start

February 28, 2022

Primary Completion

September 7, 2023

Study Completion

September 7, 2023

Last Updated

July 3, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)