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

Joint Instability Clinical Trial

— Latarjet  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02505932
• Other study ID #: APR012012
• Status: Completed
• Phase: N/A
• First received: July 20, 2015
• Last updated: July 20, 2015
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: July 2015
• Source: Hospital Ambroise Paré Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patient refusal

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Joint Instability

Intervention

Procedure:
• Arthroscopic Latarjet procedure
arthroscopic approach (set Depuy-Mitek, Raynham, MA)
• Mini-open Latarjet procedure
mini-open approach (set Arthrex, Naples, FL)

Locations

Country	Name	City	State
France	Hospital Ambroise Paré Paris	Boulogne-Billancourt
France	Clinique des Maussins	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Ambroise Paré Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average postoperative shoulder's pain on visual analogic scale from 0 (no pain) to 10 (maximum pain)		Average during the first week	No
Secondary	Mean daily pain on visual analogic scale from 0 (no pain) to 10 (maximum pain)		Daily from day1 to day7	No
Secondary	analgesic consumption (Number of pills)		Daily from day1 to day7	No
Secondary	presence of postoperative discomfort symptoms (yes/no)	The presence (yes/no) of incision site pain, nausea, vomiting, vertigo, anxiety	Daily from day1 to day7	No
Secondary	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	No
Secondary	Recurrence rate of shoulder instability (number of recurrence/total number of patients)		2-year minimal follow-up	No
Secondary	Functional evaluation of patients	Western Ontario Score Index (WOSI)	2-year minimal follow-up	No