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

July 20, 2015 updated by: Shahnaz Klouche, MD, Hospital Ambroise Paré Paris
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Boulogne-Billancourt, France, 92000
        • Hospital Ambroise Paré Paris
      • Paris, France
        • Clinique des Maussins

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Arthroscopic Latarjet procedure
arthroscopic approach (set Depuy-Mitek, Raynham, MA)
Procedure: Arthroscopic Latarjet procedure
arthroscopic approach (set Depuy-Mitek, Raynham, MA)
Mini-open Latarjet procedure
mini-open approach (set Arthrex, Naples, FL)
Procedure: Mini-open Latarjet procedure
mini-open approach (set Arthrex, Naples, FL)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean daily pain on visual analogic scale from 0 (no pain) to 10 (maximum pain)
Time Frame: Daily from day1 to day7
Daily from day1 to day7
analgesic consumption (Number of pills)
Time Frame: Daily from day1 to day7
Daily from day1 to day7
presence of postoperative discomfort symptoms (yes/no)
Time Frame: Daily from day1 to day7
The presence (yes/no) of incision site pain, nausea, vomiting, vertigo, anxiety
Daily from day1 to day7
coracoid bone block position to the anterior aspect of the glenoid on the anterior-posterior and the lateral X-ray and on CT-scan
Time Frame: Between 3 to 6 months follow-up
Between 3 to 6 months follow-up
Recurrence rate of shoulder instability (number of recurrence/total number of patients)
Time Frame: 2-year minimal follow-up
2-year minimal follow-up
Functional evaluation of patients
Time Frame: 2-year minimal follow-up
Western Ontario Score Index (WOSI)
2-year minimal follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Ambroise Paré Paris

Investigators

  • Study Director: Shahnaz Klouche, MD, Hospital Ambroise Paré Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

July 20, 2015

First Submitted That Met QC Criteria

July 20, 2015

First Posted (Estimate)

July 22, 2015

Study Record Updates

Last Update Posted (Estimate)

July 22, 2015

Last Update Submitted That Met QC Criteria

July 20, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APR012012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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