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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03656185
Other study ID # ORIF.009
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 15, 2018
Est. completion date December 31, 2024

Study information

Verified date October 2019
Source The Orthopaedic Research & Innovation Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States The Orthopaedic Research & Innovation Foundation Edgewood Kentucky

Sponsors (1)

Lead Sponsor Collaborator
The Orthopaedic Research & Innovation Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient Outcomes 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
Primary Patient Satisfaction: one question assessment one question assessment of the patients overall long term satisfaction with the outcome of the treatment. 2 years to 8 years postoperative
Primary Patient Outcomes Visual Analogue pain Scale. Scale is 0-10, 0 is no pain, 10 is the most pain preoperative to up to 8 years postoperative
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