Influenze of Approach in Reversed Shoulder Prosthesis
Primary Purpose
Outcomes Assessments, Patients, Rotator Cuff Arthropathy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Reverse Shoulder Arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Outcomes Assessments, Patients focused on measuring reverse shoulder arthroplasty, scapular notch, deltopectoral, anterosuperior approach
Eligibility Criteria
Inclusion Criteria:
- Patients with secondary osteoarthritis of the shoulder who are candidates for an inverted prosthesis
- Acute fractures <2 weeks of evolution in patients candidates for inverted prostheses
- No previous surgeries of the affected shoulder
- Acceptance by the patient to participate in the study
Exclusion Criteria:
- Fractures> 2 weeks of evolution
- Previous surgeries on the affected shoulder
- Not signing the informed consent
- Cognitive impairment
- Institutionalization of the patient
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
deltopectoral
antero-superior
Arm Description
deltopectoral surgical approach
antero-superior approach
Outcomes
Primary Outcome Measures
positioning of the metaglene of the reverse shoulder prostheses
to determine the metaglene postioning in both surgical approaches by measuring the distance between the inferior part of the metaglene and the glenoid inferior rim. The measurement will be done in an AP X-ray view of the shoulder and with the help of the measure tool in the PACS system of viewing.
Secondary Outcome Measures
scapular notch
determine scapular notch development in both approaches as determined with the aid of an AP X-ray view of the shoulder and thus classifying the scapular notch development according to Sirveaux et al. classification system.
functional outcome
determine the functional outcome as measured with the Constant Score at 2-years follow-up
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04405947
Brief Title
Influenze of Approach in Reversed Shoulder Prosthesis
Official Title
Randomized Prospective Study Comparing Reversed Shoulder Prosthesis Through the Superior Anterior Approach and the Deltopectoral Approach
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 13, 2016 (Actual)
Primary Completion Date
January 18, 2018 (Actual)
Study Completion Date
October 29, 2020 (Actual)
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
To determine the differences in the placement of the glenoid implant of the inverted prostheses when they are implanted using a superior approach and using an anterior approach.
Detailed Description
Inverted prostheses have proven to be effective in the treatment of all those pathologies that involve a deterioration of the rotator cuff (secondary arthropathy, acute fractures, sequelae of fractures, tumor surgery and revision surgery). Despite this, numerous complications have been described after the use of inverted prostheses, such as glenoid erosion, infections, dislocation, or aseptic loosening. The most frequent complication related to the use of inverted prostheses is glenoid erosion that can occur in up to 96% of cases. This complication appears early in the evolution, usually before 2 years after surgery. Its clinical significance is not yet clear, but it seems that it may be a cause of long-term prosthetic loosening. To avoid the development of glenoid erosion, the best option is to place the glenoid component low, so that if the glenoid component is flush with the lower margin of the glena, the chances of developing glenoid erosion are significantly reduced. Two types of approaches have been used to implant these prostheses, the deltopectoral and the superior anterior approach. Each of them has its advantages and disadvantages, so that deltopectoral seems to improve surgical exposure and therefore favors the best placement of the glenoid component, but sacrifices the subscapularis tendon, increasing the risk of dislocation of the components. On the contrary, the superior anterior approach respects the subscapularis tendon, reducing the risk of dislocation of the components but gives worse surgical exposure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Outcomes Assessments, Patients, Rotator Cuff Arthropathy
Keywords
reverse shoulder arthroplasty, scapular notch, deltopectoral, anterosuperior approach
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective randomized study
Masking
Outcomes Assessor
Masking Description
given the fact that the different approaches come with different scars, just the outcomes assessor can be blinded
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
deltopectoral
Arm Type
Other
Arm Description
deltopectoral surgical approach
Arm Title
antero-superior
Arm Type
Other
Arm Description
antero-superior approach
Intervention Type
Procedure
Intervention Name(s)
Reverse Shoulder Arthroplasty
Intervention Description
implantation of a reversed shoulder prostheses through two different surgical approaches
Primary Outcome Measure Information:
Title
positioning of the metaglene of the reverse shoulder prostheses
Description
to determine the metaglene postioning in both surgical approaches by measuring the distance between the inferior part of the metaglene and the glenoid inferior rim. The measurement will be done in an AP X-ray view of the shoulder and with the help of the measure tool in the PACS system of viewing.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
scapular notch
Description
determine scapular notch development in both approaches as determined with the aid of an AP X-ray view of the shoulder and thus classifying the scapular notch development according to Sirveaux et al. classification system.
Time Frame
2 years
Title
functional outcome
Description
determine the functional outcome as measured with the Constant Score at 2-years follow-up
Time Frame
2 years. The minimum value of the Constant Score is 0 and the maximum is 100. The higher scores mean a better outcome.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with secondary osteoarthritis of the shoulder who are candidates for an inverted prosthesis
Acute fractures <2 weeks of evolution in patients candidates for inverted prostheses
No previous surgeries of the affected shoulder
Acceptance by the patient to participate in the study
Exclusion Criteria:
Fractures> 2 weeks of evolution
Previous surgeries on the affected shoulder
Not signing the informed consent
Cognitive impairment
Institutionalization of the patient
12. IPD Sharing Statement
Learn more about this trial
Influenze of Approach in Reversed Shoulder Prosthesis
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