NCT00757653

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

6.2 years

First QC Date

September 22, 2008

Last Update Submit

June 16, 2017

Conditions

Femoral Neck Fractures

Outcome Measures

Primary Outcomes (1)

  • Adverse Event

    Anytime

Secondary Outcomes (1)

  • Histological Exam

    Anytime

Study Arms (3)

1

ACTIVE COMPARATOR

Stem with plasma sprayed porous Titanium 6Al4V alloy + Plasma sprayed HA

Device: Hip stem with plasma sprayed porous Ti 6Al4V alloy + plasma sprayed HA

2

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

3

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

Interventions

Hip stem with plasma sprayed porous Ti 6Al4V alloy + plasma sprayed HADEVICE

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

1
Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HADEVICE

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

2
Hip stem with Interloc Titanium surface + Bonemaster H.ADEVICE

Hip stem with Interloc Titanium surface + Bonemaster H.A

3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William Harvey Hospital

Ashford, Kent, United Kingdom

Location

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Helmut Zahn, FRCS

    William Harvey Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2008

First Posted

September 23, 2008

Study Start

October 1, 2003

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

June 20, 2017

Record last verified: 2017-06

Locations

GB(1)