A Long-term Follow Up Study of the Revelation™ Hip Stem

Encore Medical, L.P.1 site in 1 country8 target enrollmentFebruary 2012

ConditionsOsteoarthritis, Hip Complications; Arthroplasty

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteoarthritis, Hip
Sponsor: Encore Medical, L.P.
Enrollment: 8
Locations: 1
Primary Endpoint: Survivorship of the Device
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to obtain long-term (10+ yrs) clinical and patient outcomes data on patients who received the Revelation Hip Stem prior to 2002.

Registry

clinicaltrials.gov

Start Date

February 2012

End Date

July 2012

Last Updated

13 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Encore Medical, L.P.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must have received the Revelation™ Hip Stem as part of a total hip arthroplasty prior to
•Surgery must have been a primary total hip replacement
•Subject must have received only one primary hip replacement per hospitalization
•Subject must have had a diagnosis of inflammatory tissue disorder, osteoarthritis, post-traumatic arthritis/secondary arthritis or avascular necrosis
•Subject must be willing and able to sign the informed consent document

Exclusion Criteria

•Subject must not have had any previous hip implants (hemi or total joint)
•Subject has a mental condition that may interfere with the ability to give an informed consent (i.e., severe mental retardation such that the subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
•Subject is a prisoner
•Subject is pregnant

Outcomes

Primary Outcomes

Survivorship of the Device

Time Frame: 10 year

The subject meets the inclusion/exclusion criteria of the study and received a Revelation Hip Stem prior to 2002 that has survived intact without any type of surgery to revise or remove parts or the whole prosthesis.