N/A
Completed N=8
Encore Revelation Hip Stem
Osteoarthritis, Hip · Complications; Arthroplasty
Source: ClinicalTrials.gov NCT01514318 ↗
Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcomePrimary: Survivorship of the Device — 8 participants
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.
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 | — |
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
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. Informational only — not medical advice.