NCT03730597

Brief Summary

Scapular notch can be reduced by using bigger glenospheres but in some patients it cannot be implanted because of small size. If small size of glenosphere is used then scapular notch may increase. To improve that situation, eccentricity has been added to some glenospheres to increase glenoid overhanging. The objective is to assess if eccentricity can avoid scapular notch as effectively as bigger glenospheres.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration 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

September 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2016

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 5, 2018

Completed
Last Updated

March 12, 2019

Status Verified

October 1, 2018

Enrollment Period

2 years

First QC Date

October 31, 2018

Last Update Submit

March 10, 2019

Conditions

Total Shoulder Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • scapular notch development

    X-ray assessment of scapular notch development

    two years

Study Arms (2)

glenosphere 42

ACTIVE COMPARATOR

patients receiving a reverse shoulder arthroplasty with a glenosphere sized 42. reverse shoulder prosthesis implantation X-Ray analysis to detect scapular notch

Device: reverse shoulder arthroplasty

glenosphere 38 ECC

ACTIVE COMPARATOR

patients receiving a reverse shoulder arthroplasty with a glenosphere sized 38 ECC reverse shoulder prosthesis implantation X-Ray analysis to detect scapular notch

Device: reverse shoulder arthroplasty

Interventions

reverse shoulder arthroplastyDEVICE

prosthesis implantation

Also known as: Delta X-tend
glenosphere 38 ECCglenosphere 42

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing reverse shoulder prosthesis because of rotator cuff disordes andacute fractures

You may not qualify if:

  • patients with previous surgery
  • patients with deltoid deficiency
  • patients with acute infection

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
blinded to purpose of study and to randomization
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Shoulder Unit

Study Record Dates

First Submitted

October 31, 2018

First Posted

November 5, 2018

Study Start

September 1, 2014

Primary Completion

September 9, 2016

Study Completion

September 9, 2016

Last Updated

March 12, 2019

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share