Influenze of Approach in Reversed Shoulder Prosthesis

NCT ID: NCT04405947

Last Updated: 2021-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-13
• Study Completion Date: 2020-10-29

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.

Conditions

Outcomes Assessments, Patients; Rotator Cuff Arthropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

deltopectoral

deltopectoral surgical approach

Group Type: OTHER

Reverse Shoulder Arthroplasty

Intervention Type: PROCEDURE

implantation of a reversed shoulder prostheses through two different surgical approaches

antero-superior

antero-superior approach

Group Type: OTHER

Reverse Shoulder Arthroplasty

Intervention Type: PROCEDURE

implantation of a reversed shoulder prostheses through two different surgical approaches

Interventions

Reverse Shoulder Arthroplasty

implantation of a reversed shoulder prostheses through two different surgical approaches

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital del Mar

OTHER

Sponsor Role: lead

Responsible Party

Carlos Torrens

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2015/7913/I

Identifier Type: -

Identifier Source: org_study_id