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Sling vs Nothing After Latarjet Procedure

Primary Purpose

Shoulder Dislocation

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Latarjet Surgery for anterior shoulder instability
No sling in postoperative care
Sponsored by
Hugo Bothorel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Dislocation focused on measuring Latarjet, Post operative, Sling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • La Tour HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Sling Arm

No Sling Arm

Arm Description

This arm of the study will receive a sling for 3 weeks in postoperative care.

This arm of the study will not receive a sling during the postoperative care,

Outcomes

Primary Outcome Measures

Rowe score
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.

Secondary Outcome Measures

The Visual Analog Scale (VAS)
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.
Subjective Shoulder Value (SSV)
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%.
Patient satisfaction
Patients will be asked "are you satisfied, yes/no"
Bony union
Will be evaluated using a CT scan and/or X-ray
Return to work
Time, in days, till patients return to work
Return to sport
Time, in days, untill patients return to sports
Redislocation
Did the shoulder redislocate postoperatively, yes or no
Range of motion
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.

Full Information

First Posted
July 15, 2020
Last Updated
January 4, 2023
Sponsor
Hugo Bothorel
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1. Study Identification

Unique Protocol Identification Number
NCT04479397
Brief Title
Sling vs Nothing After Latarjet Procedure
Official Title
Post-operative Mobilization After Anterior Shoulder Stabilization With the Latarjet Procedure: Sling Versus Nothing. A Randomized Prospective Study.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hugo Bothorel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Dislocation
Keywords
Latarjet, Post operative, Sling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sling Arm
Arm Type
Active Comparator
Arm Description
This arm of the study will receive a sling for 3 weeks in postoperative care.
Arm Title
No Sling Arm
Arm Type
Experimental
Arm Description
This arm of the study will not receive a sling during the postoperative care,
Intervention Type
Procedure
Intervention Name(s)
Latarjet Surgery for anterior shoulder instability
Intervention Description
Bone block procedure for anterior shoulder instability
Intervention Type
Procedure
Intervention Name(s)
No sling in postoperative care
Intervention Description
No sling will be used in postoperative care.
Primary Outcome Measure Information:
Title
Rowe score
Description
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.
Time Frame
12 postoperative months
Secondary Outcome Measure Information:
Title
The Visual Analog Scale (VAS)
Description
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.
Time Frame
12 postoperative months
Title
Subjective Shoulder Value (SSV)
Description
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%.
Time Frame
12 postoperative months
Title
Patient satisfaction
Description
Patients will be asked "are you satisfied, yes/no"
Time Frame
12 postoperative months
Title
Bony union
Description
Will be evaluated using a CT scan and/or X-ray
Time Frame
12 postoperative months
Title
Return to work
Description
Time, in days, till patients return to work
Time Frame
12 postoperative months
Title
Return to sport
Description
Time, in days, untill patients return to sports
Time Frame
12 postoperative months
Title
Redislocation
Description
Did the shoulder redislocate postoperatively, yes or no
Time Frame
12 postoperative months
Title
Range of motion
Description
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.
Time Frame
12 postoperative months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandre Lädermann, PD Dr
Phone
+41227197555
Email
alexandre.laedermann@latour.ch
Facility Information:
Facility Name
La Tour Hospital
City
Meyrin
State/Province
Geneva
ZIP/Postal Code
1217
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre Lädermann, MD
Phone
+41227197555
Email
alexandre.laedermann@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
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23352473
Citation
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Sling vs Nothing After Latarjet Procedure

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