Influenze of Approach in Reversed Shoulder Prosthesis

Randomized Prospective Study Comparing Reversed Shoulder Prosthesis Through the Superior Anterior Approach and the Deltopectoral Approach

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Arthropathy; Outcomes Assessments, Patients
• Intervention / Treatment: Procedure: Reverse Shoulder Arthroplasty

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: deltopectoral; deltopectoral surgical approach	Procedure: Reverse Shoulder Arthroplasty; implantation of a reversed shoulder prostheses through two different surgical approaches
OTHER: antero-superior; antero-superior approach	Procedure: Reverse Shoulder Arthroplasty; implantation of a reversed shoulder prostheses through two different surgical approaches

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years
functional outcome	determine the functional outcome as measured with the Constant Score at 2-years follow-up	2 years. The minimum value of the Constant Score is 0 and the maximum is 100. The higher scores mean a better outcome.

Collaborators and Investigators

• Sponsor: Hospital del Mar

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 13, 2016
• Primary Completion (ACTUAL): January 18, 2018
• Study Completion (ACTUAL): October 29, 2020

Study Registration Dates

• First Submitted: May 20, 2020
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (ACTUAL): May 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 30, 2021
• Last Update Submitted That Met QC Criteria: March 25, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: reverse shoulder arthroplasty; scapular notch; deltopectoral; anterosuperior approach
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 2015/7913/I

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No