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Clinical Trials/NCT04645329
NCT04645329
Unknown
Not Applicable

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

Hospital del Mar1 site in 1 country50 target enrollmentJanuary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rotator Cuff Tear Arthropathy
Sponsor
Hospital del Mar
Enrollment
50
Locations
1
Primary Endpoint
Change in Pain control (visual analogical scale)
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
April 30, 2024
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carlos Torrens

MD, PhD

Hospital del Mar

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change in Pain control (visual analogical scale)

Time Frame: 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.

Study Sites (1)

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