Immobilization in Reverse Shoulder Prosthesis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Tear Arthropathy
• Intervention / Treatment: Device: shoulder immovilization sling

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carlos Torrens, MD, PhD; Phone Number: 0034933674201; Email: 86925@parcdesalutmar.cat

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • Recruiting
    • Hospital Del Mar
    • Contact: Carlos Torrens, MD, PhD; Phone Number: 0034933674201; Email: 86925@parcdesalutmar.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Hospital del Mar
• Investigators: Principal Investigator: Carlos Torrens, MD, PhD, Chief Clinic of Parc de Salut Mar

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): April 30, 2022
• Study Completion (Anticipated): April 30, 2024

Study Registration Dates

• First Submitted: November 17, 2020
• First Submitted That Met QC Criteria: November 20, 2020
• First Posted (Actual): November 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Arthritis; Rupture; Shoulder Injuries; Tendon Injuries; Crystal Arthropathies; Chondrocalcinosis; Rotator Cuff Injuries; Joint Diseases; Rotator Cuff Tear Arthropathy
• Other Study ID Numbers: 2019/8752/I

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No