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

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

Study Overview

• Status: Terminated
• Conditions: Femoral Neck Fractures
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Kent
    • Ashford, Kent, United Kingdom
      • William Harvey Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2	Device: Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA; Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA
Active Comparator: 3	Device: Hip stem with Interloc Titanium surface + Bonemaster H.A; Hip stem with Interloc Titanium surface + Bonemaster H.A
Active Comparator: 1; Stem with plasma sprayed porous Titanium 6Al4V alloy + Plasma sprayed HA	Device: Hip stem with plasma sprayed porous Ti 6Al4V alloy + plasma sprayed HA; Hip stem with plasma sprayed porous Titanium 6Al4V alloy + plasma sprayed HA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse Event	Anytime

Secondary Outcome Measures

Outcome Measure	Time Frame
Histological Exam	Anytime

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Collaborators: Biomet U.K. Ltd.
• Investigators: Principal Investigator: Helmut Zahn, FRCS, William Harvey Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2003
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: September 22, 2008
• First Submitted That Met QC Criteria: September 22, 2008
• First Posted (Estimate): September 23, 2008

Study Record Updates

• Last Update Posted (Actual): June 20, 2017
• Last Update Submitted That Met QC Criteria: June 16, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Femoral Neck Fractures
• Other Study ID Numbers: BMET UK 04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No