Clinical trial NCT04405947: 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
Overall status: COMPLETED
Phase: NA
Conditions: Outcomes Assessments, Patients
Rotator Cuff Arthropathy
Keywords: reverse shoulder arthroplasty
scapular notch
deltopectoral
anterosuperior approach
Lead sponsor: Hospital del Mar
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: positioning of the metaglene of the reverse shoulder prostheses
timeFrame: 2 years
Secondary outcomes:
measure: scapular notch
timeFrame: 2 years
measure: functional outcome
timeFrame: 2 years. The minimum value of the Constant Score is 0 and the maximum is 100. The higher scores mean a better outcome.
Other outcomes:
Locations:
Study officials:
References: