Clinical trial NCT02505932: Latarjet Procedure: Comparative Outcomes Study of Arthroscopic Versus Mini-open Approach With Minimum 2-year Follow-up
Official title: Latarjet Procedure: Comparative Outcomes Study of Arthroscopic Versus Mini-open Approach With Minimum 2-year Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Joint Instability
Keywords: Shoulder instability
Lead sponsor: Hospital Ambroise Paré Paris
Sponsor class: OTHER
First posted: 2015-07-22
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with a chronic anterior instability requiring bone grafting (Instability Severity Index Score\>3)

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 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).

Eligibility criteria: Inclusion Criteria:

* chronic anterior instability requiring bone grafting (Instability Severity Index Score\>3)

Exclusion Criteria:

* Patient refusal

Primary outcomes:
measure: Average postoperative shoulder's pain on visual analogic scale from 0 (no pain) to 10 (maximum pain)
timeFrame: Average during the first week
Secondary outcomes:
measure: Mean daily pain on visual analogic scale from 0 (no pain) to 10 (maximum pain)
timeFrame: Daily from day1 to day7
measure: analgesic consumption (Number of pills)
timeFrame: Daily from day1 to day7
measure: presence of postoperative discomfort symptoms (yes/no)
timeFrame: Daily from day1 to day7
measure: coracoid bone block position to the anterior aspect of the glenoid on the anterior-posterior and the lateral X-ray and on CT-scan
timeFrame: Between 3 to 6 months follow-up
measure: Recurrence rate of shoulder instability (number of recurrence/total number of patients)
timeFrame: 2-year minimal follow-up
measure: Functional evaluation of patients
timeFrame: 2-year minimal follow-up
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Hospital Ambroise Paré Paris
city: Paris
country: France
facility: Clinique des Maussins
Study officials:
affiliation: Hospital Ambroise Paré Paris
name: Shahnaz Klouche, MD
role: STUDY_DIRECTOR
References: