NCT03623269

Brief Summary

The purpose of this study is to evaluate preoperative objective measurements and operative objective measurements to determine if there is any effect to postoperative outcomes. Patients who were 18 years old or greater at the time of surgery were followed clinically and radiographically to determine best practice and optimal treatment and technique, risk and rate of complication, and postoperative outcomes.

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
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2017

Longer than P75 for all trials

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

October 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 30, 2019

Status Verified

May 1, 2019

Enrollment Period

5.9 years

First QC Date

August 7, 2018

Last Update Submit

May 29, 2019

Conditions

Total Shoulder ArthroplastyOsteo Arthritis Shoulders

Outcome Measures

Primary Outcomes (4)

  • recovery

    American shoulder and elbow score (ASES) with a range from 0-100, with 0 being worst outcome and 100 being best outcome

    preoperative to 6 months postoperatively

  • recovery

    Simple Shoulder Test score (SST) with a range from 0-12 with 12 being the best score and 0 being the worst score.

    preoperative to 6 months postoperatively

  • recovery

    range of motion

    preoperative to 6 months postoperatively

  • complications

    percent of complications

    6 months postoperative

Interventions

posterior approach to total shoulder arthroplastyPROCEDURE

The posterior approach to total shoulder arthroplasty approaches the patient from the back of the shoulder and spares the rotator cuff.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All eligible patients of the principal investigator receiving the posterior approach to total shoulder arthroplasty for any indication at our institution between September 1, 2016 and October 31, 2017 were evaluated and included in the data analysis.

You may qualify if:

  • English speaking
  • \>18 years of age
  • Underwent posterior approach to total shoulder arthroplasty by Dr. Michael Greiwe at St. Elizabeth Healthcare

You may not qualify if:

  • Non-English speaking
  • \<18 years of age
  • Loose bone in the anterior recess of the shoulder
  • Severe arthritis with significant bony deformity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Orthopaedic Research & Innovation Foundation

Edgewood, Kentucky, 41017, United States

Location

Study Officials

  • R M Greiwe, MD

    The Orthopaedic Research & Innovation Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2018

First Posted

August 9, 2018

Study Start

October 1, 2017

Primary Completion

August 31, 2023

Study Completion

December 31, 2024

Last Updated

May 30, 2019

Record last verified: 2019-05

Locations

US(1)