Encore Revelation Hip Stem

Encore Medical

Status: Completed

Conditions: Osteoarthritis, Hip; Complications; Arthroplasty

Treatments: Device: Revelation Hip Stem (Revelation)

Study type: Observational

Funder types: Industry

Identifiers

NCT01514318

PS-805

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must have received the Revelation™ Hip Stem as part of a total hip arthroplasty prior to 2002.
• 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

Trial design

8 participants in 1 patient group

Revelation

Description:

Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.

Treatment:

Device: Revelation Hip Stem (Revelation)