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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary: 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).
Sponsor: Hospital Ambroise Paré Paris

Current Primary Outcome: Average postoperative shoulder's pain on visual analogic scale from 0 (no pain) to 10 (maximum pain) [ Time Frame: Average during the first week ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mean daily pain on visual analogic scale from 0 (no pain) to 10 (maximum pain) [ Time Frame: Daily from day1 to day7 ]
  • analgesic consumption (Number of pills) [ Time Frame: Daily from day1 to day7 ]
  • presence of postoperative discomfort symptoms (yes/no) [ Time Frame: 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 [ Time Frame: Between 3 to 6 months follow-up ]
  • Recurrence rate of shoulder instability (number of recurrence/total number of patients) [ Time Frame: 2-year minimal follow-up ]
  • Functional evaluation of patients [ Time Frame: 2-year minimal follow-up ]
    Western Ontario Score Index (WOSI)


Original Secondary Outcome: Same as current

Information By: Hospital Ambroise Paré Paris

Dates:
Date Received: July 20, 2015
Date Started: January 2012
Date Completion:
Last Updated: July 20, 2015
Last Verified: July 2015