OrthoIllustrated Web Based Orthopaedic Sports Medicine Registry

This study is currently recruiting participants.

Verified June 2013 by Arthrex, Inc.

Sponsor:

Information provided by (Responsible Party):

Arthrex, Inc.

ClinicalTrials.gov Identifier:

NCT01191151

First received: August 27, 2010

Last updated: June 5, 2013

Last verified: June 2013

History of Changes

Purpose

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
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 Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Orthopaedic Sports Medicine, Arthroscopy, and Related Surgery Registry Using the Web-based OrthoIllustrated Surgical Outcome System

Resource links provided by NLM:

MedlinePlus related topics: Foot Health Sports Fitness

U.S. FDA Resources

Further study details as provided by Arthrex, Inc.:

Primary Outcome Measures:

Change in pain [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	12500
Study Start Date:	September 2010
Estimated Primary Completion Date:	June 2023 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01191151

Show 57 Study Locations

Sponsors and Collaborators

Arthrex, Inc.

Investigators

Principal Investigator:

Bryan Hanypsiak, MD

Arthrex, Inc.

More Information

Publications:

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. Review. 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.

Responsible Party:	Arthrex, Inc.
ClinicalTrials.gov Identifier:	NCT01191151 History of Changes
Other Study ID Numbers:	OrthoIllustrated SOS #1
Study First Received:	August 27, 2010
Last Updated:	June 5, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Arthrex, Inc.:

Orthopedic surgery
sports medicine

ClinicalTrials.gov processed this record on June 18, 2013

To Top