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Immobilization in Reverse Shoulder Prosthesis

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04645329
Enrollment
50
Registered
2020-11-27
Start date
2020-01-01
Completion date
2024-04-30
Last updated
2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Tear Arthropathy

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.

Interventions

DEVICEshoulder immovilization sling

immobilization of the arm after surgery

Sponsors

Hospital del Mar
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

outcomes assessor will be blinded to the allocation of the patients

Intervention model description

Randomized prospective study. (computer-generated randomization list and saved in opaque envelopes)

Eligibility

Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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.

Countries

Spain

Contacts

Primary ContactCarlos Torrens, MD, PhD
86925@parcdesalutmar.cat0034933674201

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026