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TerminatedNCT00757653Updated Jun 20, 2017

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

An interventional study of Hip stem with plasma sprayed porous Ti 6Al4V alloy + plasma sprayed HA and Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA in Femoral Neck Fractures, sponsored by Zimmer Biomet. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-20.

Sponsored by Zimmer Biomet · Not applicable, Interventional, and Treatment

Why this study was terminated
slow enrollment
Phase
Not applicable
Study type
Interventional
Enrollment
57
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Femoral Neck Fractures
03

In context

Femoral Neck Fractures

211 studies on the registry are indexed under Femoral Neck Fractures; 42 are open to participants now.

This study's enrollment of 57 is below the median of 100 across 147 interventional studies indexed under Femoral Neck Fractures.

Browse Femoral Neck Fractures studies →

Lead sponsor

Zimmer Biomet is the lead sponsor of 275 studies on the registry; 28 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 19 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria:

  • None
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
57 participants (actual)

Study arms

  • 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

  • Experimental
    2

    Device: Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA

  • Active comparator
    3

    Device: Hip stem with Interloc Titanium surface + Bonemaster H.A

Interventions

  • DeviceHip stem with plasma sprayed porous Ti 6Al4V alloy + plasma sprayed HA

    Hip stem with plasma sprayed porous Titanium 6Al4V alloy + plasma sprayed HA

  • DeviceHip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA

    Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA

  • DeviceHip stem with Interloc Titanium surface + Bonemaster H.A

    Hip stem with Interloc Titanium surface + Bonemaster H.A

06

What researchers measure

Primary outcomes

  1. Adverse Event

    Time frame: Anytime

Secondary outcomes

  1. Histological Exam

    Time frame: Anytime

07

Study locations

1 site
  • William Harvey Hospital
    Ashford, Kent, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00757653
Lead sponsor
Zimmer Biomet
Collaborators
Biomet U.K. Ltd.
Responsible party
Sponsor
First posted
Sep 23, 2008
Start date
Oct 2003
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Jun 20, 2017

Study contacts

Helmut Zahn, FRCS
principal investigator · William Harvey Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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