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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Joint Instability

Intervention / Treatment
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* Procedure: Arthroscopic Latarjet procedure
* Procedure: Mini-open Latarjet procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic anterior instability requiring bone grafting (Instability Severity Index Score>3) Exclusion Criteria: Patient refusal

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arthroscopic Latarjet procedure<br>arthroscopic approach (set Depuy-Mitek, Raynham, MA) | Procedure: Arthroscopic Latarjet procedure<br>* arthroscopic approach (set Depuy-Mitek, Raynham, MA)<br>|
| Mini-open Latarjet procedure<br>mini-open approach (set Arthrex, Naples, FL) | Procedure: Mini-open Latarjet procedure<br>* mini-open approach (set Arthrex, Naples, FL)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 | 
| presence of postoperative discomfort symptoms (yes/no) | 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 |  | Between 3 to 6 months follow-up | 
| Recurrence rate of shoulder instability (number of recurrence/total number of patients) |  | 2-year minimal follow-up | 
| Functional evaluation of patients | Western Ontario Score Index (WOSI) | 2-year minimal follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shoulder instability