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Web Based Orthopaedic Sports Medicine Registry

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ClinicalTrials.gov Identifier: NCT01191151
Recruitment Status : Recruiting
First Posted : August 30, 2010
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Arthrex, Inc.

Study Description
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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.

Condition or disease
Degenerative and Traumatic Pathology of the Knee Degenerative and Traumatic Pathology of the Shoulder and Elbow Degenerative and Traumatic Pathology of the Foot and Ankle Degenerative and Traumatic Pathology of the Hand and Wrist Degenerative and Traumatic Pathology of the Hip

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 12500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 15 Years
Official Title: Orthopaedic Sports Medicine, Arthroscopy, and Related Surgery Registry Using the Web-based OrthoIllustrated Surgical Outcomes System
Study Start Date : September 2010
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sports Fitness

Groups and Cohorts
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Group/Cohort
Orthopedic injury, osteoarthritis
All eligible patients receiving orthopedic, sports medicine, arthroscopy and related surgery or nonoperative treatment


Outcome Measures
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Primary Outcome Measures :
  1. Change in pain [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cohort will be selected from clinic patients scheduling surgery or nonoperative treatment
Criteria

Inclusion Criteria:

  • All patients electing to schedule routine and medically indicated orthopedic, sports medicine, arthroscopy and related surgery or nonoperative treatment

Exclusion Criteria:

  • Non English or Spanish speaking
  • vulnerable populations, excluding minors
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01191151


  Show 359 Study Locations
Sponsors and Collaborators
Arthrex, Inc.
Investigators
Principal Investigator: Christopher Adams, MD Arthrex, Inc.
More Information
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Publications:
Gliklich RE, Dreyer NA, eds. Registries for Evaluating Patient Outcomes: A User's Guide. AHRQ Publication No. 07-EHC001-1. Rockville, MD: Agency for Healthcare Research and Quality. April 2007.

Responsible Party: Arthrex, Inc.
ClinicalTrials.gov Identifier: NCT01191151     History of Changes
Other Study ID Numbers: SOS #1
First Posted: August 30, 2010    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018

Keywords provided by Arthrex, Inc.:
Orthopedic surgery
sports medicine