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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01191151
Registration number
NCT01191151
Ethics application status
Date submitted
27/08/2010
Date registered
30/08/2010
Date last updated
9/08/2024
Titles & IDs
Public title
Web Based Orthopaedic Sports Medicine Registry
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Scientific title
Orthopaedic Sports Medicine, Arthroscopy, and Related Surgery Registry Using the Web-based OrthoIllustrated Surgical Outcomes System
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Secondary ID [1]
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SOS #1
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Degenerative and Traumatic Pathology of the Knee
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Degenerative and Traumatic Pathology of the Shoulder and Elbow
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0
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Degenerative and Traumatic Pathology of the Foot and Ankle
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0
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Degenerative and Traumatic Pathology of the Hand and Wrist
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0
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Degenerative and Traumatic Pathology of the Hip
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0
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Condition category
Condition code
Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Orthopedic injury, osteoarthritis - All eligible patients receiving orthopedic, sports medicine, arthroscopy and related surgery or nonoperative treatment
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in pain
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Assessment method [1]
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Timepoint [1]
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2 years
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Eligibility
Key inclusion criteria
* All patients electing to schedule routine and medically indicated orthopedic, sports medicine, arthroscopy and related surgery or nonoperative treatment
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Non English or Spanish speaking
* vulnerable populations, excluding minors
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/07/2023
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Sample size
Target
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Accrual to date
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Final
12500
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
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United States of America
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State/province [2]
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Alaska
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Country [3]
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United States of America
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State/province [3]
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Arizona
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Country [4]
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United States of America
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State/province [4]
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Arkansas
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Country [5]
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United States of America
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State/province [5]
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California
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Arthrex, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to establish an international, web based clinical registry to collect baseline characteristics of patients undergoing orthopaedic, sports medicine, arthroscopy, and related surgery, and the subsequent outcomes and cost-effectiveness associated with the surgical procedures and nonoperative treatments.
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Trial website
https://clinicaltrials.gov/study/NCT01191151
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Christopher Adams, MD
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Address
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Arthrex, Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01191151
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