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

Zimmer Biomet57 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Femoral Neck Fractures

Interventions

Hip stem with plasma sprayed porous Ti 6Al4V alloy + plasma sprayed HADEVICE

Hip stem with plasma sprayed porous Titanium 6Al4V alloy + plasma sprayed HA

Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HADEVICE

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

Hip stem with Interloc Titanium surface + Bonemaster H.ADEVICE

Hip stem with Interloc Titanium surface + Bonemaster H.A

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (1)

William Harvey Hospital

Ashford, Kent, United Kingdom

Outcomes

Primary Outcomes

Adverse Event

Time frame: Anytime

Secondary Outcomes

Histological Exam

Time frame: Anytime

Data from ClinicalTrials.gov

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