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

This study has been terminated.
(slow enrollment)
Sponsor:
Collaborator:
Biomet U.K. Ltd.
Information provided by (Responsible Party):
Zimmer Biomet
ClinicalTrials.gov Identifier:
NCT00757653
First received: September 22, 2008
Last updated: June 16, 2017
Last verified: June 2017
  Purpose
Retrieval study and histological examination of BiMetric Femoral Components with hydroxyapatite coatings.

Condition Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Retrieval Study and Histological Examination Of A Hip Femoral Components With Hydroxyapatite Coatings

Resource links provided by NLM:


Further study details as provided by Zimmer Biomet:

Primary Outcome Measures:
  • Adverse Event [ Time Frame: Anytime ]

Secondary Outcome Measures:
  • Histological Exam [ Time Frame: Anytime ]

Enrollment: 57
Study Start Date: October 2003
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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   (Adult, Senior)
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT00757653     History of Changes
Other Study ID Numbers: BMET UK 04
Study First Received: September 22, 2008
Last Updated: June 16, 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

ClinicalTrials.gov processed this record on July 25, 2017