Anterior Discectomy Surgery With Arthrodesis in Degenerat... | NCT06555887

Studies
Anterior Discectomy Surgery With Arthrodesis in Degenerative Spinal Canal sténoses. (ICASC)

NCT06555887

Sponsor

University Hospital, Brest

Status

Completed

Last Update Posted

Aug 15, 2024Actual

Enrollment

14Actual

Phase

Not provided

Conditions

Lumbar Canal Stenosis

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2020Actual

Primary Completion Date

Oct 31, 2020Actual

Completion Date

Oct 31, 2020Actual

First Submitted Date

Aug 13, 2024

First Submission Date that Met QC Criteria

Aug 14, 2024

First Posted Date

Aug 15, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2024

Last Update Posted Date

Aug 15, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Single-center retrospective study to characterize changes in the functional capacity of patients (change in Oswestry Desability Index (ODI)) undergoing anterior approach surgery for the management of symptomatic lumbar spinal stenosis between the pre-surgical period and the first assessment 6 months after surgery.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
characterize the evolution of functional capacity in patients undergoing anterior approach surgery for the management of symptomatic lumbar spinal stenosis	Variation in Oswestry Desability Index (ODI) between pre-surgery and first assessment beyond 6 months post-surgery	6 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

anterior surgical management (ALIF or LLIF)
symptomatic lumbar degenerative pathology (L1-L2 to L5-S1), objectified on MRI (Schizas B, C, D)
period from June 2017 to December 2019

Exclusion Criteria:

Traumatic sprains
History of decompression after the operated stage
Operated from a later time at the same time
Scolioses with Cobb angles greater than 10°
Patients under judicial protection
Refusal to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Anterior surgery of central lumbar sténoses

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Brest		Brest		29609	France

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All collected data that underlie results in a publication

Types

Study Protocol

Time Frame

Data will be available beginning three month and ending five years following the end study

Access Criteria

Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

URL

Not provided