Immobilization in Reverse Shoulder Prosthesis
Primary Purpose
Rotator Cuff Tear Arthropathy
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
shoulder immovilization sling
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tear Arthropathy
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.
Sites / Locations
- Hospital del MarRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
group I (no immobilization)
group II (3-week immobilization)
Arm Description
patients will be allowed to freely use their arm without any immobilization after surgery
patients will be kept in an immobilization device for three weeks after surgery
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04645329
Brief Title
Immobilization in Reverse Shoulder Prosthesis
Official Title
Should Patients Undergoing Reverse Shoulder Prostheses Due to Arthropathy of the Rotator Cuff be Immobilized? Randomized Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital del Mar
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear Arthropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized prospective study. (computer-generated randomization list and saved in opaque envelopes)
Masking
Outcomes Assessor
Masking Description
outcomes assessor will be blinded to the allocation of the patients
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group I (no immobilization)
Arm Type
Experimental
Arm Description
patients will be allowed to freely use their arm without any immobilization after surgery
Arm Title
group II (3-week immobilization)
Arm Type
Active Comparator
Arm Description
patients will be kept in an immobilization device for three weeks after surgery
Intervention Type
Device
Intervention Name(s)
shoulder immovilization sling
Intervention Description
immobilization of the arm after surgery
Primary Outcome Measure Information:
Title
Change in Pain control (visual analogical scale)
Description
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.
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos Torrens, MD, PhD
Phone
0034933674201
Email
86925@parcdesalutmar.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Torrens, MD, PhD
Organizational Affiliation
Chief Clinic of Parc de Salut Mar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Torrens, MD, PhD
Phone
0034933674201
Email
86925@parcdesalutmar.cat
12. IPD Sharing Statement
Learn more about this trial
Immobilization in Reverse Shoulder Prosthesis
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