Elbow Arthroscopy Data Analysis (EA)

Retrospective Chart Analysis of Elbow Arthroscopy for the Treatment of Osteoarthritis, Radiocapitellar Plica, Lateral Epicondylitis or Osteochondritis Dissecans

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 13 years old or greater at the time of arthroscopic osteocapsular release were followed clinically and radiographically to determine best practice and optimal treatment and technique, risk and rate of complication, and postoperative outcomes.

Study Overview

Study Type

Observational

Enrollment (Anticipated)

100

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

    • 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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All eligible patients of the principal investigator receiving elbow arthroscopy for any indication at St. Elizabeth Healthcare between January 1, 2010 and October 31, 2017 will be evaluated and included in the data analysis. We anticipate approximately 150 patients to be included in the analysis.

Description

Inclusion Criteria:

  1. English speaking
  2. >13 years of age
  3. Patients treated with elbow arthroscopy for elbow arthritis, radiocapitellar plica, osteochondritis dissecans or lateral epicondylitis.

Exclusion Criteria:

  1. Non-English speaking
  2. <13 years of age

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
Patient Outcomes
Time Frame: preoperative to up to 8 years postoperative
The Quick Disabilities of the Arm, Shoulder and Hand Score. Scale of 0-100, 100 being the best possible score
preoperative to up to 8 years postoperative
Patient Satisfaction: one question assessment
Time Frame: 2 years to 8 years postoperative
one question assessment of the patients overall long term satisfaction with the outcome of the treatment.
2 years to 8 years postoperative
Patient Outcomes
Time Frame: preoperative to up to 8 years postoperative
Visual Analogue pain Scale. Scale is 0-10, 0 is no pain, 10 is the most pain
preoperative to up to 8 years postoperative

Collaborators and Investigators

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

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)

March 15, 2018

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

December 31, 2024

Study Registration Dates

First Submitted

August 30, 2018

First Submitted That Met QC Criteria

August 31, 2018

First Posted (ACTUAL)

September 4, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 25, 2019

Last Update Submitted That Met QC Criteria

October 23, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

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.

Clinical Trials on Osteochondritis Dissecans

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