Immobilization in Reverse Shoulder Prosthesis

Hospital del Mar

Status: Unknown

Conditions: Rotator Cuff Tear Arthropathy

Treatments: Device: shoulder immovilization sling

Study type: Interventional

Funder types: Other

Identifiers

NCT04645329

2019/8752/I

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 65 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

group I (no immobilization)

Experimental group

Description:

patients will be allowed to freely use their arm without any immobilization after surgery

Treatment:

Device: shoulder immovilization sling

group II (3-week immobilization)

Active Comparator group

Description:

patients will be kept in an immobilization device for three weeks after surgery

Treatment:

Device: shoulder immovilization sling