Total Hip Registry | NCT01133249

Studies
Total Hip Registry

NCT01133249

Sponsor

Heekin Orthopedic Research Institute

Status

Unknown status

Last Update Posted

Jul 26, 2016Estimated

Enrollment

942Estimated

Phase

Not provided

Conditions

Osteoarthritis

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

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

May 26, 2010

First Submission Date that Met QC Criteria

May 27, 2010

First Posted Date

May 28, 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

Jul 22, 2016

Last Update Posted Date

Jul 26, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

R. David Heekin, MD, R. David Heekin, M.D., Heekin Orthopedic Research InstitutePrincipal Investigator

Lead Sponsor

Heekin Orthopedic Research InstituteOTHER

Collaborators

Name	Class
Stryker Orthopaedics	INDUSTRY
DePuy Orthopaedics	INDUSTRY
Restor3D	INDUSTRY

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

Objective

Describe the clinical and demographic characteristics of patients who undergo hip arthroplasty and document post operative outcomes.

Examine the relationship between processes of care, hospital and surgeon associated outcomes

Provide expanded data to characterize existing and evolving practice patterns, delivery of care, and resource utilization in the management of knee arthroplasty patients.

Analyze and design ancillary studies to address unanswered questions.

Disseminate findings through publication in peer-reviewed scientific journals.

Detailed Description

Not provided

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

942Estimated

Label	Type	Description	Intervention Names
Total hip		all consented patients receiving total hip arthroplasty

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Harris Hip Score		2 weeks, 6 weeks, 3 months, 6 months, 1, 2, 5, 10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient requires total hip Arthroplasty
Patient has signed IRB approved informed consent

Exclusion Criteria:

Less than 21 years of age
Patient is a prisoner

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

93 Years

Standard Ages

AdultOlder Adult

Study Population

Population: All total hip replacements

Selection: Males and non-pregnant females over the age of 21

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard D Heekin, MD	Heekin Orthopedic Specialists	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Heekin Orthopedic Specialists		Jacksonville	Florida	32204	United States

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided