Femoral Neck FracturesNCT00757653
Retrieval Study and Histological Examination Of A Hip Femoral Components With Hydroxyapatite Coatings
A study testing Hip stem with plasma sprayed porous Ti 6Al4V alloy + plasma sprayed HA, Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA and Hip stem with Interloc Titanium surface + Bonemaster H.A in people with Femoral Neck Fractures, run by Zimmer Biomet at 1 site in United Kingdom.
Trial summary
Retrieval study and histological examination of BiMetric Femoral Components with hydroxyapatite coatings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- Hip stem with plasma sprayed porous Ti 6Al4V alloy + plasma sprayed HA, Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA and Hip stem with Interloc Titanium surface + Bonemaster H.A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2003to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Femoral Neck Fractures
- Being tested
- Hip stem with plasma sprayed porous Ti 6Al4V alloy + plasma sprayed HA, Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA, Hip stem with Interloc Titanium surface + Bonemaster H.A
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip stem with plasma sprayed porous Ti 6Al4V alloy + plasma sprayed HADevice
Hip stem with plasma sprayed porous Titanium 6Al4V alloy + plasma sprayed HA
Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HADevice
Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA
Hip stem with Interloc Titanium surface + Bonemaster H.ADevice
Hip stem with Interloc Titanium surface + Bonemaster H.A
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Stem with plasma sprayed porous Titanium 6Al4V alloy + Plasma sprayed HA Receives: Device: Hip stem with plasma sprayed porous Ti 6Al4V alloy + plasma sprayed HA |
| 2 | Experimental | Not described Receives: Device: Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA |
| 3 | Active comparator | Not described Receives: Device: Hip stem with Interloc Titanium surface + Bonemaster H.A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event
Measured: Anytime
Secondary outcomes (1)
Histological Exam
Measured: Anytime
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2008 (estimated)
- Study startOct 2003
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FracturesStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomet U.K. Ltd.
- Responsible party
- Sponsor
- Investigators
- Helmut Zahn, FRCS, Principal investigator, William Harvey Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757653
- Sponsor's protocol ID
- BMET UK 04
- Status last verified
- Jun 2017
- First submitted
- 22 Sep 2008
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrieval Study and Histological Examination Of A Hip Femoral Components With Hydroxyapatite Coatings
- ClinicalTrials.gov ID
- NCT00757653
- Acronym / sponsor ID
- BMET UK 04
- Conditions
- Femoral Neck Fractures
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrollment
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Collaborators
- Biomet U.K. Ltd.
- Study start
- Oct 2003
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 23 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrieval study and histological examination of BiMetric Femoral Components with hydroxyapatite coatings.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Hip stem with plasma sprayed porous Ti 6Al4V alloy + plasma sprayed HAStem with plasma sprayed porous Titanium 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hip stem with plasma sprayed porous Ti 6Al4V alloy + plasma sprayed HAHip stem with plasma sprayed porous Titanium 6Al4V alloy + plasma sprayed HA | Device | 1 |
| Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HAHip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA | Device | 2 |
| Hip stem with Interloc Titanium surface + Bonemaster H.AHip stem with Interloc Titanium surface + Bonemaster H.A | Device | 3 |
Primary outcome
Adverse Event
Time frame: Anytime
1 secondary outcome
Histological Exam
Time frame: Anytime
Results and safety
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helmut Zahn, FRCS principal investigator
William Harvey Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip stem with plasma sprayed porous Ti 6Al4V alloy + plasma sprayed HA, Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA and Hip stem with Interloc Titanium surface + Bonemaster H.A in people with Femoral Neck Fractures, run by Zimmer Biomet at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event (time frame: Anytime). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2017.