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
About this trial
This is an interventional treatment trial for Femoral Neck Fractures
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
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
NCT ID
NCT00757653
First Posted
September 22, 2008
Last Updated
June 16, 2017
Sponsor
Zimmer Biomet
Collaborators
Biomet U.K. Ltd.
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
Learn more about this trial
Retrieval Study and Histological Examination Of A Hip Femoral Components With Hydroxyapatite Coatings
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