Immobilization in Reverse Shoulder Prosthesis

Study Overview
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Brief Summary
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Reverse shoulder prostheses are the treatment of choice in elderly patients with rotator cuff arthropathy. Traditionally these patients have been immobilized for 3 weeks in the immediate postoperative period in order to have good pain control. However, there are no studies that determine the most appropriate period of immobilization. In fact, patients undergoing this type of surgery begin rehabilitation exercises within 24 hours of surgery without experiencing increased pain or requiring specific analgesic treatment. There is a demand in the elderly to limit immobilization time as much as possible, as some live alone and need to be self-sufficient and others have dependents. It would be good to know if it is really necessary to make an immobilization in these patients undergoing this type of surgery.

Official Title
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Should Patients Undergoing Reverse Shoulder Prostheses Due to Arthropathy of the Rotator Cuff be Immobilized? Randomized Prospective Study

Conditions
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Rotator Cuff Tear Arthropathy

Intervention / Treatment
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* Device: shoulder immovilization sling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing primary surgery of inverted prosthesis for rotator cuff arthropathy. age between 65-85 a. without inflammatory pathologies (rheumatoid arthritis, psoriatic arthritis, ...) acceptance to be part of the study. Exclusion Criteria: prosthetic surgery prior to the affected limb. other indications of reverse prosthesis other than rotator cuff arthropathies (acute fractures, sequelae fractures, tumor surgery, prosthetic revision surgeries). no acceptance to participate in the study.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized prospective study. (computer-generated randomization list and saved in opaque envelopes)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group I (no immobilization)<br>patients will be allowed to freely use their arm without any immobilization after surgery | Device: shoulder immovilization sling<br>* immobilization of the arm after surgery<br>|
| Active Comparator: group II (3-week immobilization)<br>patients will be kept in an immobilization device for three weeks after surgery | Device: shoulder immovilization sling<br>* immobilization of the arm after surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain control (visual analogical scale) | determination of pain control between groups at different time points with the aid of a visual analogical scale of 10 points, where 0 means no pain and 10 means maximum pain. | determination of pain the day of the surgery, and then 24hours, 48hours, 7 days, 3-weeks, 3 months, 6 months, 1 year, 2 years postoperatively. |