Osteoarthritis Elbow LeftEANCT03656185
Elbow Arthroscopy Data Analysis
An observational study of Osteoarthritis Elbow Left and Osteoarthritis Elbow Right, run by The Orthopaedic Research & Innovation Foundation at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis Elbow Left, Osteoarthritis Elbow Right, Lateral Epicondylitis, Left Elbow
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2018to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older adult
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.
Who may be able to join
- English speaking
- >13 years of age
- Patients treated with elbow arthroscopy for elbow arthritis, radiocapitellar plica, osteochondritis dissecans or lateral epicondylitis.
Who cannot join
- Non-English speaking
- <13 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
The Orthopaedic Research & Innovation Foundation
Edgewood, Kentucky, 41017
About this study
Official title: 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.
- Conditions
- Osteoarthritis Elbow Left, Osteoarthritis Elbow Right, Lateral Epicondylitis, Left Elbow, Lateral Epicondylitis, Right Elbow, Plica Syndromes, Osteochondritis Dissecans
- Medical subject headings
- Tennis Elbow, Synovitis, Osteochondritis Dissecans
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Outcomes
The Quick Disabilities of the Arm, Shoulder and Hand Score. Scale of 0-100, 100 being the best possible score
Measured: preoperative to up to 8 years postoperative
Patient Satisfaction: one question assessment
one question assessment of the patients overall long term satisfaction with the outcome of the treatment.
Measured: 2 years to 8 years postoperative
Patient Outcomes
Visual Analogue pain Scale. Scale is 0-10, 0 is no pain, 10 is the most pain
Measured: preoperative to up to 8 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start15 Mar 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis Elbow LeftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Orthopaedic Research & Innovation Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656185
- Sponsor's protocol ID
- ORIF.009
- Acronym
- EA
- Status last verified
- Oct 2019
- First submitted
- 30 Aug 2018
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Chart Analysis of Elbow Arthroscopy for the Treatment of Osteoarthritis, Radiocapitellar Plica, Lateral Epicondylitis or Osteochondritis Dissecans
- ClinicalTrials.gov ID
- NCT03656185
- Acronym / sponsor ID
- EA / ORIF.009
- Conditions
- Osteoarthritis Elbow Left, Osteoarthritis Elbow Right, Lateral Epicondylitis, Left Elbow, Lateral Epicondylitis, Right Elbow, Plica Syndromes, Osteochondritis Dissecans
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Orthopaedic Research & Innovation FoundationUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 4 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- English speaking
- >13 years of age
- Patients treated with elbow arthroscopy for elbow arthritis, radiocapitellar plica, osteochondritis dissecans or lateral epicondylitis.
Key exclusion criteria (2 listed)
- Non-English speaking
- <13 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis Elbow Left and Osteoarthritis Elbow Right, run by The Orthopaedic Research & Innovation Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Outcomes (time frame: preoperative to up to 8 years postoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2019; AzTrials last refreshed its copy on 27 Oct 2026.