NCT03922763

Brief Summary

The purpose of the present study is to determine if a standard humeral cut using a fixed neck shaft angled prosthesis for patients undergoing anatomic TSA is able to restore normal glenohumeral relationships as compared to a variable neck shaft angle prosthesis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

February 2, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2020

Completed
Last Updated

April 22, 2019

Status Verified

April 1, 2019

Enrollment Period

1 year

First QC Date

April 17, 2019

Last Update Submit

April 19, 2019

Conditions

Shoulder Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Radriographic measurements

    x-rays will be measured by 3 independent surgeons to measure restoration to natural anatomy following total shoulder replacement

    x-rays taken day of surgery

Study Arms (2)

Anatomically-matched cut

ACTIVE COMPARATOR
Procedure: Anatomical cut

Cutting guide

ACTIVE COMPARATOR
Procedure: Cutting guide

Interventions

Anatomical cutPROCEDURE

Surgeon-derived cut based on patient's anatomy

Anatomically-matched cut
Cutting guidePROCEDURE

Angle cut at 132.5 degrees based on cutting guide

Cutting guide

Eligibility Criteria

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

You may qualify if:

  • patients 18 years or older
  • primary glenohumeral osteoarthritis
  • intact rotator cuff
  • primary anatomic shoulder arthroplasty

You may not qualify if:

  • revision arthroplasty
  • reverse shoulder arthroplasty candidates
  • cognitive or behavioral problems which would preclude informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2019

First Posted

April 22, 2019

Study Start

February 2, 2019

Primary Completion

February 2, 2020

Study Completion

May 2, 2020

Last Updated

April 22, 2019

Record last verified: 2019-04

Locations

US(1)