Posterior Approach to Total Shoulder Arthroplasty (pTSA)

May 29, 2019 updated by: The Orthopaedic Research & Innovation Foundation

Posterior Approach to Total Shoulder Arthroplasty: A Data Analysis on Patients Undergoing the Posterior Approach to Total Shoulder Arthroplasty

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • The Orthopaedic Research & Innovation Foundation

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  1. English speaking
  2. >18 years of age
  3. Underwent posterior approach to total shoulder arthroplasty by Dr. Michael Greiwe at St. Elizabeth Healthcare

Exclusion Criteria:

  1. Non-English speaking
  2. <18 years of age
  3. Loose bone in the anterior recess of the shoulder
  4. Severe arthritis with significant bony deformity

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recovery
Time Frame: preoperative to 6 months postoperatively
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
Time Frame: preoperative to 6 months postoperatively
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
Time Frame: preoperative to 6 months postoperatively
range of motion
preoperative to 6 months postoperatively
complications
Time Frame: 6 months postoperative
percent of complications
6 months postoperative

Collaborators and Investigators

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

Sponsor

The Orthopaedic Research & Innovation Foundation

Investigators

  • Principal Investigator: R M Greiwe, MD, The Orthopaedic Research & Innovation Foundation

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)

October 1, 2017

Primary Completion (Anticipated)

August 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

August 7, 2018

First Submitted That Met QC Criteria

August 7, 2018

First Posted (Actual)

August 9, 2018

Study Record Updates

Last Update Posted (Actual)

May 30, 2019

Last Update Submitted That Met QC Criteria

May 29, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORIF.005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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