Clinical trial NCT04479397: 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
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Dislocation
Keywords: Latarjet
Post operative
Sling
Lead sponsor: La Tour Hospital
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Rowe score
timeFrame: 12 postoperative months
Secondary outcomes:
measure: The Visual Analog Scale (VAS)
timeFrame: 12 postoperative months
measure: Subjective Shoulder Value (SSV)
timeFrame: 12 postoperative months
measure: Patient satisfaction
timeFrame: 12 postoperative months
measure: Bony union
timeFrame: 12 postoperative months
measure: Return to work
timeFrame: 12 postoperative months
measure: Return to sport
timeFrame: 12 postoperative months
measure: Redislocation
timeFrame: 12 postoperative months
measure: Range of motion
timeFrame: 12 postoperative months
Other outcomes:
Locations:
city: Meyrin
country: Switzerland
facility: La Tour Hospital
state: Geneva
Study officials:
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