Influenze of Approach in Reversed Shoulder Prosthesis

Rotator Cuff Arthropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04405947
• Other study ID #: 2015/7913/I
• Status: Completed
• Phase: N/A
• Start date: January 13, 2016
• Est. completion date: October 29, 2020

Study information

• Verified date: March 2021
• Source: Hospital del Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 29, 2020
• Est. primary completion date: January 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Joint Diseases
• Outcomes Assessments, Patients
• Rotator Cuff Arthropathy

Intervention

Procedure:
• Reverse Shoulder Arthroplasty
implantation of a reversed shoulder prostheses through two different surgical approaches

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital del Mar

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.