Sling vs Nothing After Latarjet Procedure

March 20, 2024 updated by: Hugo Bothorel

Post-operative Mobilization After Anterior Shoulder Stabilization With the Latarjet Procedure: Sling Versus Nothing. A Randomized Prospective Study.

Traumatic anterior shoulder instability is a common injury for the contact athlete, with high rates of recurrence in some athletic populations. The specific indication for the Latarjet procedure differs amongst surgeons, however it is generally accepted that it is indicated in patients with anterior glenohumeral instability that are unlikely to have a successful outcome from either an arthroscopic or open anatomical Bankart repair.

Overall the rate of reoperation following a Latarjet is around 5-7%. Infection, hematoma as well as screw removal and glenoid bony rim fractures are the most common indications for reoperation. The rate of instability after a Latarjet is low, with 1.7%-5.0% rate of dislocation.

However, in terms of rehabilitation, there are only a few studies and evidence of best practices. A recent review of the literature has highlighted four studies, comparing different rehabilitation protocols, which include different immobilization periods ranging from 0 to 3 weeks, and different types of mobilization (under physiotherapist supervision or not, with machine or not). They found a similar rate of recurrent dislocation between the different protocols. But early passive motion enables to improve the range of motion during first 3-6 months, with similar results at one year.

One main aspect which the surgeon can influence is immobilization time. In all above-mentioned studies, patients had to wear a sling for at least 3 weeks, even in the early mobilization groups. Short protocols with encouraging results have been recently emphasized by in other fields of shoulder surgery. The investigators would like to determine if the absence of postoperative immobilization could lead to improved function and better range of motion. To the investigators best knowledge, no study has sought to compare the usefulness of sling wearing after Latarjet procedure. Avoiding the sling could simplify rehabilitation and should provide a return to normal function faster.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to compare rehabilitation with the wearing of a sling, to rehabilitation without any immobilization after Latarjet procedure for treatment of anterior shoulder instability. Ultimately, the goal would be to offer to patients a simplified rehabilitation management, with a faster recovery, less pain and a quicker return to activities of daily living, work and sport.

As primary outcome, investigators will evaluate if the Rowe score is superior without postoperative immobilization (without a sling during the first 3 weeks) at 6 months after surgery compared to sling wearing.

Secondary outcomes include radiological criteria (X-rays and computed tomography (CT) at 6 months for bony union), return to sport, work absenteeism, other complication rate (especially redislocation), and the undermentioned subjective and clinical scores before surgery and at 1.5, 6 and 12 postoperative months.

All patients will be assessed with commonly used subjective scores in the form of self-administered questionnaires. The Visual Analog Scale (VAS) is a widely used single-item test where a patient rates pain intensity between 0 and 10. This scale is useful for patient preoperative and postoperative monitoring and has also been correlated with patient pain, anxiety and apprehension. Patient satisfaction (are patients satisfied, yes/no) will be assessed as well. Subjective Shoulder Value (SSV) is a single-question test where a patient is asked to rate his overall shoulder function as a percentage of normal shoulder. It is a quick and easily administered score that has also been validated for various shoulder disabilities, such as instability.

The following clinical scores will be analyzed as well Rowe score for instability is a three-item test with four choices each, measuring shoulder function, stability, and motion. The final result is converted into a value between 0 and 100. These scores have been specifically developed for shoulder instability.

Except for VAS, higher results mean higher function. ROM will be determined using a Vicon motion capture system (Vicon, Oxford Metrics, Oxford, UK) consisting of six cameras sampling at 120 Hz already available in our facility.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
    • Geneva
      • Meyrin, Geneva, Switzerland, 1217
        • La Tour Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • all patients over 18 years old who have an anterior shoulder instability with one of the following criteria: an anterior glenoid bone defect > 20%, contact athlete or patients with failed Bankart repair-either open or arthroscopic will be considered eligible.

Exclusion Criteria:

  • We exclude patients with a subscapularis tear, other trauma of the involved upper extremity (e.g. associated scapular or clavicular fractures, acromioclavicular dislocation), pre-operative stiffness, pre-operative sign of dislocation on standard X-ray, CT, CT arthrogram, MRI or MRA, contra-indication to CT (i.e pregnancy), and an inability to follow properly post-surgery recommendations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sling Arm
This arm of the study will receive a sling for 3 weeks in postoperative care.
Procedure: Latarjet Surgery for anterior shoulder instability
Bone block procedure for anterior shoulder instability
Experimental: No Sling Arm
This arm of the study will not receive a sling during the postoperative care,
Procedure: Latarjet Surgery for anterior shoulder instability
Bone block procedure for anterior shoulder instability
Procedure: No sling in postoperative care
No sling will be used in postoperative care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rowe score
Time Frame: 12 postoperative months
The Rowe Score consists of a total of 100 points divided into three domains: (1) stability, which corresponds to a total 50 points; (2) mobility, which corresponds to 20 points; (3) function, which corresponds to 30 points.
12 postoperative months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Visual Analog Scale (VAS)
Time Frame: 12 postoperative months
The Visual Analog Scale (VAS) is a widely used single-item test where a patient rates pain intensity between 0 and 10. This scale is useful for patient preoperative and postoperative monitoring and has also been correlated with patient pain, anxiety and apprehension.
12 postoperative months
Subjective Shoulder Value (SSV)
Time Frame: 12 postoperative months
The SSV is defined as a patient's subjective shoulder assessment expressed as a percent- age of an entirely normal shoulder, which would score 100%.
12 postoperative months
Patient satisfaction
Time Frame: 12 postoperative months
Patients will be asked "are you satisfied, yes/no"
12 postoperative months
Bony union
Time Frame: 12 postoperative months
Will be evaluated using a CT scan and/or X-ray
12 postoperative months
Return to work
Time Frame: 12 postoperative months
Time, in days, till patients return to work
12 postoperative months
Return to sport
Time Frame: 12 postoperative months
Time, in days, untill patients return to sports
12 postoperative months
Redislocation
Time Frame: 12 postoperative months
Did the shoulder redislocate postoperatively, yes or no
12 postoperative months
Range of motion
Time Frame: 12 postoperative months
ROM will be determined using a Vicon motion capture system (Vicon, Oxford Metrics, Oxford, UK) consisting of six cameras sampling at 120 Hz already available in our facility.
12 postoperative months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hugo Bothorel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

July 15, 2020

First Submitted That Met QC Criteria

July 20, 2020

First Posted (Actual)

July 21, 2020

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-02469

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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