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Completed

NCT Number: NCT02505932

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

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.

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Key information

Conditions

Joint Instability Joint Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Ambroise Paré Paris, Boulogne-Billancourt, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patient refusal

Treatment and study plan

Arthroscopic Latarjet procedure

Procedure

arthroscopic approach (set Depuy-Mitek, Raynham, MA)

Mini-open Latarjet procedure

Procedure

mini-open approach (set Arthrex, Naples, FL)

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Hospital Ambroise Paré Paris

Other

Registry information

Acronym: Latarjet

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 22, 2015
Registry last updated
Jul 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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