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

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ClinicalTrials.gov Identifier: NCT00757653
Recruitment Status : Terminated (slow enrollment)
First Posted : September 23, 2008
Last Update Posted : June 20, 2017
Sponsor:
Collaborator:
Biomet U.K. Ltd.
Information provided by (Responsible Party):
Zimmer Biomet

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

Condition or disease Intervention/treatment Phase
Femoral Neck Fractures 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 Not Applicable

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  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Retrieval Study and Histological Examination Of A Hip Femoral Components With Hydroxyapatite Coatings
Study Start Date : October 2003
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. Adverse Event [ Time Frame: Anytime ]

Secondary Outcome Measures :
  1. Histological Exam [ Time Frame: Anytime ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00757653


Locations
United Kingdom
William Harvey Hospital
Ashford, Kent, United Kingdom
Sponsors and Collaborators
Zimmer Biomet
Biomet U.K. Ltd.
Investigators
Principal Investigator: Helmut Zahn, FRCS William Harvey Hospital

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT00757653     History of Changes
Other Study ID Numbers: BMET UK 04
First Posted: September 23, 2008    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Femoral Neck Fractures
Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries