Retrieval Study and Histological Examination Of A Hip Femoral Components With Hydroxyapatite Coatings - Full Text View

Sponsored by:	Biomet, Inc.
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00757653

Purpose

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

Condition	Intervention
Fractured Neck of Femur Requiring Hemi-Arthroplasty	Device: Hip stem with plasma sprayed porous Titanium 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

MedlinePlus related topics: Fractures

Drug Information available for: Durapatite

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Retrieval Study and Histological Examination Of A Hip Femoral Components With Hydroxyapatite Coatings

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:

Adverse Event [ Time Frame: Anytime ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Histological Exam [ Time Frame: Anytime ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	October 2003
Estimated Study Completion Date:	October 2020
Estimated Primary Completion Date:	October 2020 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Stem with plasma sprayed porous Titanium 6Al4V alloy + Plasma sprayed HA	Device: Hip stem with plasma sprayed porous Titanium 6Al4V alloy + plasma sprayed HA Hip stem with plasma sprayed porous Titanium 6Al4V alloy + plasma sprayed HA
2: Experimental	Device: Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA
3: Active Comparator	Device: Hip stem with Interloc Titanium surface + Bonemaster H.A 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757653

Contacts

Contact: David Stephenson, PhD

david.stephenson@biometeurope.com

Locations

United Kingdom, Kent
William Harvey Hospital	Recruiting
Ashford, Kent, United Kingdom
Contact: H Zahn, F.R.C.S

Sponsors and Collaborators

Biomet, Inc.

Investigators

Principal Investigator:

Helmut Zahn, FRCS

William Harvey Hospital

More Information

No publications provided

Responsible Party:	Biomet UK ( David Stephenson )
Study ID Numbers:	BMET UK 04
Study First Received:	September 22, 2008
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00757653 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee

Study placed in the following topic categories:

Femoral Neck Fractures
Hip Fractures
Femoral Fractures
Fractures, Bone

Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries

Additional relevant MeSH terms:

Femoral Neck Fractures
Hip Fractures
Femoral Fractures
Fractures, Bone

Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries

ClinicalTrials.gov processed this record on May 07, 2009