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

Completed

• Conditions: Joint Instability
• Interventions: Procedure: Mini-open Latarjet procedure; Procedure: Arthroscopic Latarjet procedure

• Registration Number: NCT02505932
• Lead Sponsor: Hospital Ambroise Paré Paris

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).

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2014-01
• Study Completion: 2014-12
• Status Verified: 2015-07
• Study First Submitted: 2015-07-20
• Study First Submitted QC: 2015-07-20
• Last Update Submitted: 2015-07-20
• Study First Posted: 2015-07-22
• Last Update Posted: 2015-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

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

Exclusion Criteria

• Patient refusal

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mini-open Latarjet procedure	Mini-open Latarjet procedure	mini-open approach (set Arthrex, Naples, FL)
Arthroscopic Latarjet procedure	Arthroscopic Latarjet procedure	arthroscopic approach (set Depuy-Mitek, Raynham, MA)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Recurrence rate of shoulder instability (number of recurrence/total number of patients)	2-year minimal follow-up
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
presence of postoperative discomfort symptoms (yes/no)	Daily from day1 to day7	The presence (yes/no) of incision site pain, nausea, vomiting, vertigo, anxiety
coracoid bone block position to the anterior aspect of the glenoid on the anterior-posterior and the lateral X-ray and on CT-scan	Between 3 to 6 months follow-up
Functional evaluation of patients	2-year minimal follow-up	Western Ontario Score Index (WOSI)

Trial Locations

Locations (2)

Hospital Ambroise Paré Paris; 🇫🇷 Boulogne-Billancourt, France

Clinique des Maussins; 🇫🇷 Paris, France