ClinicalTrials.gg
Status unknownNCT03656185EAUpdated Oct 25, 2019

Elbow Arthroscopy Data Analysis

An observational study in Osteoarthritis Elbow Left, Osteoarthritis Elbow Right and Lateral Epicondylitis, Left Elbow, sponsored by The Orthopaedic Research & Innovation Foundation. Status unknown at 1 site in United States. Per ClinicalTrials.gov, last updated 2019-10-25.

Sponsored by The Orthopaedic Research & Innovation Foundation · Observational

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
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Study 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.

02

Conditions studied

  • Osteoarthritis Elbow Left
  • Osteoarthritis Elbow Right
  • Lateral Epicondylitis, Left Elbow
  • Lateral Epicondylitis, Right Elbow
  • Plica Syndromes
  • Osteochondritis Dissecans
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In context

Tennis Elbow

296 studies on the registry are indexed under Tennis Elbow; 64 are open to participants now.

This study's planned enrollment of 100 is above the median of 90 across 29 observational studies indexed under Tennis Elbow.

Browse Tennis Elbow studies →

Lead sponsor

The Orthopaedic Research & Innovation Foundation is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Patient Outcomes

    The Quick Disabilities of the Arm, Shoulder and Hand Score. Scale of 0-100, 100 being the best possible score

    Time frame: preoperative to up to 8 years postoperative

  2. Patient Satisfaction: one question assessment

    one question assessment of the patients overall long term satisfaction with the outcome of the treatment.

    Time frame: 2 years to 8 years postoperative

  3. Patient Outcomes

    Visual Analogue pain Scale. Scale is 0-10, 0 is no pain, 10 is the most pain

    Time frame: preoperative to up to 8 years postoperative

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Study locations

1 site
  • The Orthopaedic Research & Innovation Foundation
    Edgewood, Kentucky 41017, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2018 (actual). Primary completion is estimated for Dec 2023, 69 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 30, 2018
First posted
Sep 4, 2018
StartActual
Mar 15, 2018
Primary completionEst.
Dec 31, 2023
CompletionEst.
Dec 31, 2024
Last update
Oct 25, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03656185
Lead sponsor
The Orthopaedic Research & Innovation Foundation
Responsible party
Sponsor
First posted
Sep 4, 2018
Start date
Mar 15, 2018
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Oct 25, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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