Clinical Trials Directory

Trials / Completed

CompletedNCT02505932

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

Status
Completed
Phase
Study type
Observational
Enrollment
58 (actual)
Sponsor
Hospital Ambroise Paré Paris · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
PROCEDUREArthroscopic Latarjet procedurearthroscopic approach (set Depuy-Mitek, Raynham, MA)
PROCEDUREMini-open Latarjet proceduremini-open approach (set Arthrex, Naples, FL)

Timeline

Start date
2012-01-01
Primary completion
2014-01-01
Completion
2014-12-01
First posted
2015-07-22
Last updated
2015-07-22

Locations

2 sites across 1 country: France

Source: ClinicalTrials.gov record NCT02505932. Inclusion in this directory is not an endorsement.