Web Based Orthopaedic Sports Medicine Registry | NCT01191151

Studies
Web Based Orthopaedic Sports Medicine Registry

NCT01191151

Sponsor

Arthrex, Inc.

Status

Terminated

Last Update Posted

Aug 9, 2024Actual

Enrollment

12,500Actual

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

United States
Canada
Puerto Rico
South Africa
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor made buisness decision to close SOS Software, and terminate collecting data

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Jul 30, 2023Actual

Completion Date

Jul 30, 2023Actual

First Submitted Date

Aug 27, 2010

First Submission Date that Met QC Criteria

Aug 27, 2010

First Posted Date

Aug 30, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2024

Last Update Posted Date

Aug 9, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Conditions Module

Conditions

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

Keywords

Orthopedic surgery
sports medicine

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

15 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12,500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Orthopedic injury, osteoarthritis		All eligible patients receiving orthopedic, sports medicine, arthroscopy and related surgery or nonoperative treatment

Interventions

Not provided

Measure	Description	Time Frame
Change in pain		2 years

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Cohort will be selected from clinic patients scheduling surgery or nonoperative treatment

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christopher Adams, MD	Arthrex, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Andrews Sports Medicine & Orthopedic Center		Birmingham	Alabama	35205	United States
Southern Orthopaedic Surgeons

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21204321	Background	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/
20360530	Background	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.