Latarjet Procedure: Comparative Outcomes Study of Arthroscopic Versus Mini-open Approach With Minimum 2-year Follow-up
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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)
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
- Recurrence rate of shoulder instability (number of recurrence/total number of patients) [2-year minimal follow-up]
- Functional evaluation of patients [2-year minimal follow-up]
Western Ontario Score Index (WOSI)
Eligibility Criteria
Criteria
Inclusion Criteria:
- chronic anterior instability requiring bone grafting (Instability Severity Index Score>3)
Exclusion Criteria:
- Patient refusal
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Ambroise Paré Paris | Boulogne-Billancourt | France | 92000 | |
| 2 | Clinique des Maussins | Paris | France |
Sponsors and Collaborators
- Hospital Ambroise Paré Paris
Investigators
- Study Director: Shahnaz Klouche, MD, Hospital Ambroise Paré Paris
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- APR012012