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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02505932
Other study ID # APR012012
Secondary ID
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


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
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