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

Not Applicable

Terminated

• Conditions: Femoral Neck Fractures
• Interventions: Device: Hip stem with plasma sprayed porous Ti 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

• Registration Number: NCT00757653
• Lead Sponsor: Zimmer Biomet

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.

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2008-09-22
• Study First Submitted QC: 2008-09-22
• Study First Posted: 2008-09-23
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-16
• Last Update Posted: 2017-06-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 57

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Hip stem with plasma sprayed porous Ti 6Al4V alloy + plasma sprayed HA	Stem with plasma sprayed porous Titanium 6Al4V alloy + Plasma sprayed HA
2	Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA	-
3	Hip stem with Interloc Titanium surface + Bonemaster H.A	-

Primary Outcome Measures

Name	Time	Method
Adverse Event	Anytime

Secondary Outcome Measures

Name	Time	Method
Histological Exam	Anytime

Trial Locations

Locations (1)

William Harvey Hospital; 🇬🇧 Ashford, Kent, United Kingdom