NCT04405947

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2018

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2020

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

2 years

First QC Date

May 20, 2020

Last Update Submit

March 25, 2021

Conditions

Outcomes Assessments, PatientsRotator Cuff Arthropathy

Keywords

reverse shoulder arthroplastyscapular notchdeltopectoralanterosuperior approach

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • scapular notch

    2 years

  • functional outcome

    2 years. The minimum value of the Constant Score is 0 and the maximum is 100. The higher scores mean a better outcome.

Study Arms (2)

deltopectoral

OTHER

deltopectoral surgical approach

Procedure: Reverse Shoulder Arthroplasty

antero-superior

OTHER

antero-superior approach

Procedure: Reverse Shoulder Arthroplasty

Interventions

Reverse Shoulder ArthroplastyPROCEDURE

implantation of a reversed shoulder prostheses through two different surgical approaches

antero-superiordeltopectoral

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Fractures\> 2 weeks of evolution
  • Previous surgeries on the affected shoulder
  • Not signing the informed consent
  • Cognitive impairment
  • Institutionalization of the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
given the fact that the different approaches come with different scars, just the outcomes assessor can be blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: prospective randomized study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 20, 2020

First Posted

May 28, 2020

Study Start

January 13, 2016

Primary Completion

January 18, 2018

Study Completion

October 29, 2020

Last Updated

March 30, 2021

Record last verified: 2021-03