- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03656185
Elbow Arthroscopy Data Analysis (EA)
October 23, 2019 updated by: The Orthopaedic Research & Innovation Foundation
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
Status
Active, not recruiting
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
-
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Kentucky
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Edgewood, Kentucky, United States, 41017
- The Orthopaedic Research & Innovation Foundation
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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:
- English speaking
- >13 years of age
- Patients treated with elbow arthroscopy for elbow arthritis, radiocapitellar plica, osteochondritis dissecans or lateral epicondylitis.
Exclusion Criteria:
- Non-English speaking
- <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
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Patient Satisfaction: one question assessment
Time Frame: 2 years to 8 years postoperative
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one question assessment of the patients overall long term satisfaction with the outcome of the treatment.
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2 years to 8 years postoperative
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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
Additional Relevant MeSH Terms
- Wounds and Injuries
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Muscular Diseases
- Tendon Injuries
- Bone Diseases
- Tendinopathy
- Arm Injuries
- Elbow Tendinopathy
- Cartilage Diseases
- Osteoarthritis
- Tennis Elbow
- Synovitis
- Osteochondritis
- Osteochondritis Dissecans
Other Study ID Numbers
- ORIF.009
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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