Latarjet Procedure: Comparative Outcomes Study of Arthros... | NCT02505932

Studies
Latarjet Procedure: Comparative Outcomes Study of Arthroscopic Versus Mini-open Approach With Minimum 2-year Follow-up

NCT02505932

Sponsor

Hospital Ambroise Paré Paris

Status

Completed

Last Update Posted

Jul 22, 2015Estimated

Enrollment

58Actual

Phase

Not provided

Conditions

Joint Instability

Interventions

Arthroscopic Latarjet procedure
Mini-open Latarjet procedure

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

Jul 2015

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

Jan 2012

Primary Completion Date

Jan 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Jul 20, 2015

First Submission Date that Met QC Criteria

Jul 20, 2015

First Posted Date

Jul 22, 2015Estimated

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

Jul 20, 2015

Last Update Posted Date

Jul 22, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shahnaz Klouche, MD, Physician responsible of clinical research, Hospital Ambroise Paré ParisPrincipal Investigator

Lead Sponsor

Hospital Ambroise Paré ParisOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

To date, use of arthroscopic procedure to perform Latarjet procedure is still technically demanding. The benefits of arthroscopic procedure need to be evaluated compared to the mini-invasive approach. The aim of this study was to assess postoperative pain during the first week, and the positioning of coracoid bone block at the anterior aspect of the glenoid. At minimum 2 years follow-up, the recurrence of shoulder instability and functional evaluation of patients according to the Western Ontario Score Index (WOSI) were assessed.

Detailed Description

This prospective comparative study was performed at two centers in 2012. Each center performed one procedure so this study was observational. All patients with a chronic anterior instability requiring bone grafting (Instability Severity Index Score>3) were included. The Latarjet procedure was performed by mini-open approach (set Arthrex, Naples, FL) in the first group, and by arthroscopic approach (set Depuy-Mitek, Raynham, MA) in the second group. The analgesic postoperative protocol was standardized (paracetamol, non-steroidal anti-inflammatory, tramadol).

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

58Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arthroscopic Latarjet procedure		arthroscopic approach (set Depuy-Mitek, Raynham, MA)	Procedure: Arthroscopic Latarjet procedure
Mini-open Latarjet procedure		mini-open approach (set Arthrex, Naples, FL)	Procedure: Mini-open Latarjet procedure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Arthroscopic Latarjet procedure	Procedure	arthroscopic approach (set Depuy-Mitek, Raynham, MA)	Arthroscopic Latarjet procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Average postoperative shoulder's pain on visual analogic scale from 0 (no pain) to 10 (maximum pain)		Average during the first week

Secondary Outcomes

Measure	Description	Time Frame
Mean daily pain on visual analogic scale from 0 (no pain) to 10 (maximum pain)		Daily from day1 to day7
analgesic consumption (Number of pills)		Daily from day1 to day7

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

chronic anterior instability requiring bone grafting (Instability Severity Index Score>3)

Exclusion Criteria:

Patient refusal

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients with a chronic anterior instability requiring bone grafting (Instability Severity Index Score>3)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shahnaz Klouche, MD	Hospital Ambroise Paré Paris	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Ambroise Paré Paris		Boulogne-Billancourt		92000	France
Clinique des Maussins

Condition Browse Module

MeSH Terms

ID	Term
D007593	Joint Instability

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

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Browse Branches

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