Retrieval Study and Histological Examination Of A Hip Femoral Components With Hydroxyapatite Coatings

Zimmer Biomet

Status: Terminated

Conditions: Femoral Neck Fractures

Treatments: Device: Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA; Device: Hip stem with plasma sprayed porous Ti 6Al4V alloy + plasma sprayed HA; Device: Hip stem with Interloc Titanium surface + Bonemaster H.A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00757653

BMET UK 04

Details and patient eligibility

About

Retrieval study and histological examination of BiMetric Femoral Components with hydroxyapatite coatings.

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 3 patient groups

1

Active Comparator group

Description:

Stem with plasma sprayed porous Titanium 6Al4V alloy + Plasma sprayed HA

Treatment:

Device: Hip stem with plasma sprayed porous Ti 6Al4V alloy + plasma sprayed HA

2

Experimental group

Treatment:

Device: Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA

3

Active Comparator group

Treatment:

Device: Hip stem with Interloc Titanium surface + Bonemaster H.A