Total Hip Registry

This study is enrolling participants by invitation only.

Sponsor:

Collaborators:

Stryker Orthopaedics

DePuy Orthopaedics

ConforMIS, Inc.

Information provided by (Responsible Party):

R. David Heekin, Heekin Orthopedic Research Institute

ClinicalTrials.gov Identifier:

NCT01133249

First received: May 26, 2010

Last updated: March 19, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

May 26, 2010

Last Updated Date

March 19, 2013

Start Date ^ICMJE

July 2005

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Harris Hip Score [ Time Frame: 2 weeks, 6 weeks, 3 months, 6 months, 1, 2, 5, 10 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01133249 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Total Hip Registry

Official Title ^ICMJE

Total Hip Registry

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

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Population: All total hip replacements

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

Condition ^ICMJE

Osteoarthritis

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Total hip

all consented patients receiving total hip arthroplasty

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

942

Completion Date

Not Provided

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01133249

Other Study ID Numbers ^ICMJE

05-09-01

Has Data Monitoring Committee

Responsible Party

R. David Heekin, Heekin Orthopedic Research Institute

Study Sponsor ^ICMJE

Heekin Orthopedic Research Institute

Collaborators ^ICMJE

Stryker Orthopaedics
DePuy Orthopaedics
ConforMIS, Inc.

Investigators ^ICMJE

Principal Investigator:

Richard D Heekin, MD

Heekin Orthopedic Specialists

Information Provided By

Heekin Orthopedic Research Institute

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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