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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Arthroscopic Latarjet procedure | arthroscopic approach (set Depuy-Mitek, Raynham, MA) |
| PROCEDURE | Mini-open Latarjet procedure | mini-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.