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NCT00757653 Clinical Trial

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

Femoral Neck Fractures Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00757653
Other study ID # BMET UK 04
Secondary ID
Status Terminated
Phase N/A
First received September 22, 2008
Last updated June 16, 2017
Start date October 2003
Est. completion date December 2009

Study information
Verified date June 2017
Source Zimmer Biomet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 57
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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
• Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA
Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA
• Hip stem with Interloc Titanium surface + Bonemaster H.A
Hip stem with Interloc Titanium surface + Bonemaster H.A

Locations
Country Name City State
United Kingdom William Harvey Hospital Ashford Kent

Sponsors (2)
Lead Sponsor Collaborator
Zimmer Biomet Biomet U.K. Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse Event Anytime
Secondary Histological Exam Anytime
See also
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Recruiting NCT04589598 - Femoral Neck System and Multiple Cannulated Screws in Femoral Neck Fracture N/A
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Active, not recruiting NCT02246335 - Hemiarthroplasty Compared to Total Hip Arthroplasty for Displaced Femoral Neck Fractures in the Elderly-elderly N/A
Not yet recruiting NCT00926666 - A Dose Finding Study for Pain Relief of a Broken Hip Phase 4