Influenze of Approach in Reversed Shoulder Prosthesis

Not Applicable

Completed

• Conditions: Rotator Cuff Arthropathy; Outcomes Assessments, Patients
• Interventions: Procedure: Reverse Shoulder Arthroplasty

• Registration Number: NCT04405947
• Lead Sponsor: Hospital del Mar

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.

Study Timeline

• Study Start: 2016-01-13
• Primary Completion: 2018-01-18
• Study First Submitted: 2020-05-20
• Study First Submitted QC: 2020-05-27
• Study First Posted: 2020-05-28
• Study Completion: 2020-10-29
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-25
• Last Update Posted: 2021-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

• Fractures> 2 weeks of evolution
• Previous surgeries on the affected shoulder
• Not signing the informed consent
• Cognitive impairment
• Institutionalization of the patient

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
antero-superior	Reverse Shoulder Arthroplasty	antero-superior approach
deltopectoral	Reverse Shoulder Arthroplasty	deltopectoral surgical approach

Primary Outcome Measures

Name	Time	Method
positioning of the metaglene of the reverse shoulder prostheses	2 years	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

Name	Time	Method
scapular notch	2 years	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	2 years. The minimum value of the Constant Score is 0 and the maximum is 100. The higher scores mean a better outcome.	determine the functional outcome as measured with the Constant Score at 2-years follow-up