Femoral Neck Fractures
Conditions
Brief summary
Retrieval study and histological examination of BiMetric Femoral Components with hydroxyapatite coatings.
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.
Interventions
DEVICEHip stem with plasma sprayed porous Ti 6Al4V alloy + plasma sprayed HA
Hip stem with plasma sprayed porous Titanium 6Al4V alloy + plasma sprayed HA
DEVICEHip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA
Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA
DEVICEHip stem with Interloc Titanium surface + Bonemaster H.A
Hip stem with Interloc Titanium surface + Bonemaster H.A
Sponsors
Biomet U.K. Ltd.
Zimmer Biomet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event | Anytime |
Secondary
| Measure | Time frame |
|---|---|
| Histological Exam | Anytime |
Countries
United Kingdom
Outcome results
None listed