Immobilization in Reverse Shoulder Prosthesis

Rotator Cuff Tear Arthropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04645329
• Other study ID #: 2019/8752/I
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: April 30, 2024

Study information

• Verified date: March 2022
• Source: Hospital del Mar
• Contact: Carlos Torrens, MD, PhD
• Phone: 0034933674201
• Email: 86925[@]parcdesalutmar.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Joint Diseases
• Rotator Cuff Injuries
• Rotator Cuff Tear Arthropathy

Intervention

Device:
• shoulder immovilization sling
immobilization of the arm after surgery

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital del Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.