N/A N=8

Encore Revelation Hip Stem

Osteoarthritis, Hip · Complications; Arthroplasty

Bottom Line

View on ClinicalTrials.gov: NCT01514318 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2012

Primary outcome: Primary: Survivorship of the Device — 8 participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Revelation Hip Stem (Revelation) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Encore Medical, L.P.
Primary completion: Jul 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Survivorship of the Device	8	—
SECONDARY Western Ontario McMaster Arthritis Index (WOMAC)	17.4	—
SECONDARY Harris Hip Score	82.4	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01514318). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.