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Elbow Arthroscopy Data Analysis (EA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03656185
Recruitment Status : Active, not recruiting
First Posted : September 4, 2018
Last Update Posted : October 25, 2019
Sponsor:
Information provided by (Responsible Party):
The Orthopaedic Research & Innovation Foundation

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 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.

Condition or disease
Osteoarthritis Elbow Left Osteoarthritis Elbow Right Lateral Epicondylitis, Left Elbow Lateral Epicondylitis, Right Elbow Plica Syndromes Osteochondritis Dissecans

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Chart Analysis of Elbow Arthroscopy for the Treatment of Osteoarthritis, Radiocapitellar Plica, Lateral Epicondylitis or Osteochondritis Dissecans
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024





Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03656185


Locations
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United States, Kentucky
The Orthopaedic Research & Innovation Foundation
Edgewood, Kentucky, United States, 41017
Sponsors and Collaborators
The Orthopaedic Research & Innovation Foundation
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Responsible Party: The Orthopaedic Research & Innovation Foundation
ClinicalTrials.gov Identifier: NCT03656185    
Other Study ID Numbers: ORIF.009
First Posted: September 4, 2018    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Tennis Elbow
Osteochondritis
Osteochondritis Dissecans
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries
Bone Diseases
Cartilage Diseases
Connective Tissue Diseases