NCT03656185

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 4, 2018

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 25, 2019

Status Verified

October 1, 2019

Enrollment Period

5.8 years

First QC Date

August 30, 2018

Last Update Submit

October 23, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • English speaking
  • \>13 years of age
  • Patients treated with elbow arthroscopy for elbow arthritis, radiocapitellar plica, osteochondritis dissecans or lateral epicondylitis.

You may not qualify if:

  • Non-English speaking
  • \<13 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Orthopaedic Research & Innovation Foundation

Edgewood, Kentucky, 41017, United States

Location

MeSH Terms

Conditions

Tennis ElbowSynovitisOsteochondritis Dissecans

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon InjuriesJoint DiseasesOsteochondritisBone Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2018

First Posted

September 4, 2018

Study Start

March 15, 2018

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

October 25, 2019

Record last verified: 2019-10

Locations