Skip to main content
OpenTrials
Completed

NCT Number: NCT04405947

Influenze of Approach in Reversed Shoulder Prosthesis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Outcomes Assessments, Patients Rotator Cuff Arthropathy

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reverse Shoulder Arthroplasty

Procedure

implantation of a reversed shoulder prostheses through two different surgical approaches

Primary outcomes

  1. positioning of the metaglene of the reverse shoulder prostheses

    Time frame: 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 outcomes

  1. scapular notch

    Time frame: 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.

  2. functional outcome

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospital del Mar

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
May 28, 2020
Registry last updated
Mar 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.