Trial Review

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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
Scientific title
Orthopaedic Sports Medicine, Arthroscopy, and Related Surgery Registry Using the Web-based OrthoIllustrated Surgical Outcomes System
Secondary ID [1] 0 0
SOS #1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Degenerative and Traumatic Pathology of the Knee 0 0
Degenerative and Traumatic Pathology of the Shoulder and Elbow 0 0
Degenerative and Traumatic Pathology of the Foot and Ankle 0 0
Degenerative and Traumatic Pathology of the Hand and Wrist 0 0
Degenerative and Traumatic Pathology of the Hip 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Orthopedic injury, osteoarthritis - All eligible patients receiving orthopedic, sports medicine, arthroscopy and related surgery or nonoperative treatment
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in pain
Timepoint [1] 0 0
2 years

Eligibility
Key inclusion criteria
- All patients electing to schedule routine and medically indicated orthopedic, sports
medicine, arthroscopy and related surgery or nonoperative treatment
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Non English or Spanish speaking

- vulnerable populations, excluding minors

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2023
Actual
Sample size
Target
12500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Alaska
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United States of America
State/province [3] 0 0
Arizona
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Connecticut
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United States of America
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Delaware
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United States of America
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District of Columbia
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United States of America
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Florida
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Georgia
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Idaho
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kansas
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Maine
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United States of America
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Maryland
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United States of America
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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United States of America
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Missouri
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United States of America
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Montana
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United States of America
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Nevada
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United States of America
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New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Rhode Island
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United States of America
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South Carolina
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United States of America
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South Dakota
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United States of America
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Tennessee
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United States of America
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Texas
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Utah
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United States of America
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Vermont
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United States of America
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Virginia
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United States of America
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Washington
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United States of America
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West Virginia
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United States of America
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Wisconsin
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Canada
State/province [46] 0 0
British Columbia
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Canada
State/province [47] 0 0
Ontario
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Puerto Rico
State/province [48] 0 0
San Juan
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South Africa
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Ballitoville
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South Africa
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Berea
Country [51] 0 0
South Africa
State/province [51] 0 0
Cape Town
Country [52] 0 0
South Africa
State/province [52] 0 0
Durban
Country [53] 0 0
South Africa
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Howick
Country [54] 0 0
South Africa
State/province [54] 0 0
Lyttelton
Country [55] 0 0
South Africa
State/province [55] 0 0
Newton Park
Country [56] 0 0
South Africa
State/province [56] 0 0
Northdale
Country [57] 0 0
South Africa
State/province [57] 0 0
Pietermaritzburg
Country [58] 0 0
South Africa
State/province [58] 0 0
Pinetown
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South Africa
State/province [59] 0 0
Plattekloof
Country [60] 0 0
South Africa
State/province [60] 0 0
Rietfontein
Country [61] 0 0
South Africa
State/province [61] 0 0
Rosebank
Country [62] 0 0
South Africa
State/province [62] 0 0
Umhlanga
Country [63] 0 0
South Africa
State/province [63] 0 0
Westville
Country [64] 0 0
United Kingdom
State/province [64] 0 0
West Midlands
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Middlesex
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Ottershaw
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Oxford
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Poole
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Reading
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Southampton
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Stirling
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Stockton-on-Tees
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Walsall
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Wigan
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Windsor

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Arthrex, Inc.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01191151
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.
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

Contacts
Principal investigator
Name 0 0
Christopher Adams, MD
Address 0 0
Arthrex, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01191151