Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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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
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
Stopped early
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
Actual
30/07/2023
Sample size
Target
Accrual to date
Final
12500
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
Arizona
Country [4] 0 0
United States of America
State/province [4] 0 0
Arkansas
Country [5] 0 0
United States of America
State/province [5] 0 0
California

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/study/NCT01191151
Trial related presentations / publications
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/study/NCT01191151