Latarjet Procedure: Comparative Outcomes Study of Arthroscopic Versus Mini-open Approach With Minimum 2-year Follow-up
Latarjet
1 other identifier
observational
58
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2012
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 20, 2015
CompletedFirst Posted
Study publicly available on registry
July 22, 2015
CompletedJuly 22, 2015
July 1, 2015
2 years
July 20, 2015
July 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Average postoperative shoulder's pain on visual analogic scale from 0 (no pain) to 10 (maximum pain)
Average during the first week
Secondary Outcomes (6)
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
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
- +1 more secondary outcomes
Study Arms (2)
Arthroscopic Latarjet procedure
arthroscopic approach (set Depuy-Mitek, Raynham, MA)
Mini-open Latarjet procedure
mini-open approach (set Arthrex, Naples, FL)
Interventions
arthroscopic approach (set Depuy-Mitek, Raynham, MA)
mini-open approach (set Arthrex, Naples, FL)
Eligibility Criteria
All patients with a chronic anterior instability requiring bone grafting (Instability Severity Index Score\>3)
You may qualify if:
- chronic anterior instability requiring bone grafting (Instability Severity Index Score\>3)
You may not qualify if:
- Patient refusal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hospital Ambroise Paré Paris
Boulogne-Billancourt, 92000, France
Clinique des Maussins
Paris, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shahnaz Klouche, MD
Hospital Ambroise Paré Paris
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician responsible of clinical research
Study Record Dates
First Submitted
July 20, 2015
First Posted
July 22, 2015
Study Start
January 1, 2012
Primary Completion
January 1, 2014
Study Completion
December 1, 2014
Last Updated
July 22, 2015
Record last verified: 2015-07