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

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ClinicalTrials.gov Identifier: NCT02505932
Recruitment Status : Completed
First Posted : July 22, 2015
Last Update Posted : July 22, 2015
Sponsor:
Information provided by (Responsible Party):
Shahnaz Klouche, MD, Hospital Ambroise Paré Paris

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.

Condition or disease Intervention/treatment
Joint Instability Procedure: Arthroscopic Latarjet procedure Procedure: Mini-open Latarjet procedure

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).

Study Type : Observational
Actual Enrollment : 58 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Latarjet Procedure: Comparative Outcomes Study of Arthroscopic Versus Mini-open Approach With Minimum 2-year Follow-up
Study Start Date : January 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : December 2014

Group/Cohort Intervention/treatment
Arthroscopic Latarjet procedure
arthroscopic approach (set Depuy-Mitek, Raynham, MA)
Procedure: Arthroscopic Latarjet procedure
arthroscopic approach (set Depuy-Mitek, Raynham, MA)

Mini-open Latarjet procedure
mini-open approach (set Arthrex, Naples, FL)
Procedure: Mini-open Latarjet procedure
mini-open approach (set Arthrex, Naples, FL)




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

Secondary Outcome Measures :
  1. Mean daily pain on visual analogic scale from 0 (no pain) to 10 (maximum pain) [ Time Frame: Daily from day1 to day7 ]
  2. analgesic consumption (Number of pills) [ Time Frame: Daily from day1 to day7 ]
  3. 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

  4. 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 ]
  5. Recurrence rate of shoulder instability (number of recurrence/total number of patients) [ Time Frame: 2-year minimal follow-up ]
  6. Functional evaluation of patients [ Time Frame: 2-year minimal follow-up ]
    Western Ontario Score Index (WOSI)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with a chronic anterior instability requiring bone grafting (Instability Severity Index Score>3)
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient refusal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02505932


Locations
France
Hospital Ambroise Paré Paris
Boulogne-Billancourt, France, 92000
Clinique des Maussins
Paris, France
Sponsors and Collaborators
Hospital Ambroise Paré Paris
Investigators
Study Director: Shahnaz Klouche, MD Hospital Ambroise Paré Paris

Responsible Party: Shahnaz Klouche, MD, Physician responsible of clinical research, Hospital Ambroise Paré Paris
ClinicalTrials.gov Identifier: NCT02505932     History of Changes
Other Study ID Numbers: APR012012
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: July 22, 2015
Last Verified: July 2015

Keywords provided by Shahnaz Klouche, MD, Hospital Ambroise Paré Paris:
Shoulder instability

Additional relevant MeSH terms:
Joint Instability
Joint Diseases
Musculoskeletal Diseases