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

Primary Purpose

Femoral Neck Fractures

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Hip stem with plasma sprayed porous Ti 6Al4V alloy + plasma sprayed HA
Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA
Hip stem with Interloc Titanium surface + Bonemaster H.A
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Neck Fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • William Harvey Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

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

Outcomes

Primary Outcome Measures

Adverse Event

Secondary Outcome Measures

Histological Exam

Full Information

First Posted
September 22, 2008
Last Updated
June 16, 2017
Sponsor
Zimmer Biomet
Collaborators
Biomet U.K. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00757653
Brief Title
Retrieval Study and Histological Examination Of A Hip Femoral Components With Hydroxyapatite Coatings
Official Title
Retrieval Study and Histological Examination Of A Hip Femoral Components With Hydroxyapatite Coatings
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
slow enrollment
Study Start Date
October 2003 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
Collaborators
Biomet U.K. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Stem with plasma sprayed porous Titanium 6Al4V alloy + Plasma sprayed HA
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Hip stem with plasma sprayed porous Ti 6Al4V alloy + plasma sprayed HA
Intervention Description
Hip stem with plasma sprayed porous Titanium 6Al4V alloy + plasma sprayed HA
Intervention Type
Device
Intervention Name(s)
Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA
Intervention Description
Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA
Intervention Type
Device
Intervention Name(s)
Hip stem with Interloc Titanium surface + Bonemaster H.A
Intervention Description
Hip stem with Interloc Titanium surface + Bonemaster H.A
Primary Outcome Measure Information:
Title
Adverse Event
Time Frame
Anytime
Secondary Outcome Measure Information:
Title
Histological Exam
Time Frame
Anytime

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helmut Zahn, FRCS
Organizational Affiliation
William Harvey Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
William Harvey Hospital
City
Ashford
State/Province
Kent
Country
United Kingdom

12. IPD Sharing Statement

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

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