Immobilization in Reverse Shoulder Prosthesis

Not Applicable

• Conditions: Rotator Cuff Tear Arthropathy
• Interventions: Device: shoulder immovilization sling

• Registration Number: NCT04645329
• Lead Sponsor: Hospital del Mar

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-11-17
• Study First Submitted QC: 2020-11-20
• Study First Posted: 2020-11-27
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-30
• Last Update Posted: 2022-03-31
• Primary Completion: 2022-04-30
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group II (3-week immobilization)	shoulder immovilization sling	patients will be kept in an immobilization device for three weeks after surgery
group I (no immobilization)	shoulder immovilization sling	patients will be allowed to freely use their arm without any immobilization after surgery

Primary Outcome Measures

Name	Time	Method
Change in Pain control (visual analogical scale)	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.	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.

Trial Locations

Locations (1)

Hospital del Mar; 🇪🇸 Barcelona, Spain