Influenze of Approach in Reversed Shoulder Prosthesis

March 25, 2021 updated by: Carlos Torrens, Hospital del Mar

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 years
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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital del Mar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 13, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 18, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 29, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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