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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01191151
Registration number
NCT01191151
Ethics application status
Date submitted
27/08/2010
Date registered
30/08/2010
Date last updated
15/02/2022
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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Degenerative and Traumatic Pathology of the Foot and Ankle
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Degenerative and Traumatic Pathology of the Hand and Wrist
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Degenerative and Traumatic Pathology of the Hip
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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
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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
Unknown status
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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
1/06/2023
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Actual
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Sample size
Target
12500
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Accrual to date
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Final
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Arthrex, Inc.
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Ethics approval
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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/ct2/show/NCT01191151
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Trial related presentations / publications
Gliklich RE, Dreyer NA, editors. Registries for Evaluating Patient Outcomes: A User's Guide. 2nd edition. Rockville (MD): Agency for Healthcare Research and Quality (US); 2010 Sep. Available from http://www.ncbi.nlm.nih.gov/books/NBK49444/
Schemitsch EH, Bhandari M, Boden SD, Bourne RB, Bozic KJ, Jacobs JJ, Zdero R. The evidence-based approach in bringing new orthopaedic devices to market. J Bone Joint Surg Am. 2010 Apr;92(4):1030-7. doi: 10.2106/JBJS.H.01532. No abstract available.
Capozzi JD, Rhodes R. Examining the ethical implications of an orthopaedic joint registry. J Bone Joint Surg Am. 2010 May;92(5):1330-3. doi: 10.2106/JBJS.I.01410.
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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
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Christopher Adams, MD
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Address
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Arthrex, Inc.
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01191151
Download to PDF