Clinical Orthopaedic Data Bank (Acute and Chronic) | NCT00411060

Studies
Clinical Orthopaedic Data Bank (Acute and Chronic)

NCT00411060

Sponsor

University of Florida

Status

Recruiting

Last Update Posted

Aug 6, 2025Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Osteoarthritis
Osteosarcoma
Scoliosis
Cerebral Palsy

Interventions

Not provided

Countries

United States

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
117-2006	Other Identifier	Legacy study
OCR18422	Other Identifier	Universiy of Florida

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Aug 14, 2026Estimated

Completion Date

Aug 14, 2026Estimated

First Submitted Date

Dec 12, 2006

First Submission Date that Met QC Criteria

Dec 12, 2006

First Posted Date

Dec 13, 2006Estimated

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 5, 2025

Last Update Posted Date

Aug 6, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Data involving orthopaedic conditions and rehabilitation aspects of musculoskeletal and neuromuscular disorders will be collected and stored as part of the normal clinical care of patients seen in the University of Florida (UF) and Shands Orthopaedics and Sports Medicine Institute.

Detailed Description

All patients seen the Orthopaedic clinic will be informed of the data collection and asked to participate. If the patient is agreeable to participation, informed consent will then be obtained.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retrospective data	Medical Record information will be used as needed for a future IRB retrospective study	2007 to present, until 2020

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients seen in the UF&Shands Orthopaedics and Sports Medicine Institute will be asked to sign an informed consent.

Exclusion Criteria:

No exclusions, all patients interested in participation will be asked to sign an informed consent.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Orthopaedic clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
MaryBeth Horodyski, EdD	Contact	352-273-7379		horodmb@ortho.ufl.edu

Overall Officials

Name	Affiliation	Role
Parker Gibbs, MD	UF Department of Orthopaedics and Rehabilitation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UF&Shands Orthopaedics and Sports Medicine Institute	Recruiting	Gainesville	Florida	32607	United States

Label	URL
University of Florida Department of Orthopaedics Research	View source

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis
D012516	Osteosarcoma
D012600	Scoliosis
D002547	Cerebral Palsy
D000070636	Rotator Cuff Injuries

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided