Retrieval Study and Histological Examination Of A Hip Femoral Components With Hydroxyapatite Coatings
Information source: Biomet, Inc.
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fractured Neck of Femur Requiring Hemi-Arthroplasty
Intervention: Hip stem with plasma sprayed porous Titanium 6Al4V alloy + plasma sprayed HA (Device); Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA (Device); Hip stem with Interloc Titanium surface + Bonemaster H.A (Device)
Phase: N/A
Status: Recruiting
Sponsored by: Biomet, Inc. Official(s) and/or principal investigator(s):
Helmut Zahn, FRCS, Principal Investigator, Affiliation: William Harvey Hospital
Overall contact:
David Stephenson, PhD, Email: david.stephenson@biometeurope.com
Summary
Retrieval study and histological examination of BiMetric Femoral Components with
hydroxyapatite coatings.
Clinical Details
Official title: Retrieval Study and Histological Examination Of A Hip Femoral Components With Hydroxyapatite Coatings
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Adverse Event
Secondary outcome: Histological Exam
Detailed description:
A single type of femoral component with 3 different HA coatings will be evaluated in this
study. Patients with fractured neck of femur requiring hemi-arthroplasty will be recruited.
Safety and performance of the device will be determined by adverse events (device related or
non-related), survival and histological exam.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Fractured neck of femur requiring hemi-arthroplasty. Selection of subjects for this
evaluation should include the following considerations:-.
- A likelihood of obtaining relief of pain and improved function.
- Full skeletal maturity.
- Ability to follow instructions.
- Good general health for age.
- Willing to return for follow-up evaluations .
- No bias to sex.
Exclusion criteria:
• None
Locations and Contacts
David Stephenson, PhD, Email: david.stephenson@biometeurope.com
William Harvey Hospital, Ashford, Kent, United Kingdom; Recruiting
H Zahn, F.R.C.S
Additional Information
Starting date: October 2003
Ending date: October 2020
Last updated: September 22, 2008
|
