Arthroplasty, Replacement, HipNCT00958347
Omnifit Hydroxylapatite (HA) Hip Outcomes Study
A study testing Omnifit HA Hip Stem in people with Arthroplasty, Replacement, Hip, run by Stryker Orthopaedics at 4 sites in 2 countries.
Trial summary
The purpose of this study was to obtain up to 25 year post-operative data on the Omnifit Hydroxylapatite (HA) Hip System in support of the hypothesis that it is a satisfactory system for reducing implant loosening, permitting tissue bonding onto the hydroxylapatite surfaces of the implant and providing a safe… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- Omnifit HA Hip Stem
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Oct 1987to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- For use as a universal hip replacement:
- Acute femoral neck fracture.
- Non-union of femoral head and neck fractures.
- Aseptic necrosis of the femoral head.
- Osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
- Salvage of failed total hip arthroplasty.
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- For use as a total hip replacement:
- Severely disabled joints resulting from painful osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty, or other procedure.
Who cannot join
- Active infection in or near the hip joint.
- Pathological bone conditions which would significantly compromise the ability to carry physiologic stress levels and for which bone grafting would be inappropriate (i.e. severe osteoporosis, Paget's Disease, renal osteodystrophy, etc.).
- Neuro-muscular disorders in which the potentially adverse effects on prosthesis function are not outweighed by the benefits to be gained by the patient from usage of the implant.
- Mental disorders which would compromise essential patient post-operative care.
- Skeletal immaturity.
- Extreme obesity.
- Significant probability that patient could not return for required follow-up evaluations.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Indiana University Medical Center
Indianapolis, Indiana, 46202
Sewickley Valley Hospital
Moon Township, Pennsylvania, 15108-4305
Hospital for Joint Disease/ Orthopaedic Institute
New York, New York, 10128
About this study
The purpose of this study was to obtain up to 25 year post-operative data on the Omnifit Hydroxylapatite (HA) Hip System in support of the hypothesis that it is a satisfactory system for reducing implant loosening, permitting tissue bonding onto the hydroxylapatite surfaces of the implant and providing a safe, efficient, and well-functioning hip in a wide spectrum of clinical circumstances.
- Conditions
- Arthroplasty, Replacement, Hip
- Being tested
- Omnifit HA Hip Stem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omnifit HA Hip StemDevice
Total Hip Replacement with Omnifit HA Hip Stem
| Study group | Role | What they receive |
|---|---|---|
| Omnifit HA Hip Stem | Other | Participants underwent total hip replacement surgery using the Omnifit HA Hip Stem. Receives: Device: Omnifit HA Hip Stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients Will be Evaluated for Pain, Functional Level, and Clinical Complications Utilizing the Harris Hip Score.
Measured: 25 Years Post-Operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startOct 1987
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: Terminated due to lagging follow-up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arthroplasty, Replacement, HipStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Capello, MD, Study chair, Indiana University Medical CenterWilliam Jaffe, MD, Principal investigator, Hospital for Joint Disease/ Orthopaedic InstituteRudolph Geesink, MD, Principal investigator, Trialbureau OrthopedicsJames D'Antonio, MD, Study chair, Sewickley Valley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958347
- Sponsor's protocol ID
- 01/04
- Status last verified
- Jul 2014
- First submitted
- 11 Aug 2009
- Last updated
- 19 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omnifit Hydroxylapatite (HA) Hip Outcomes Study
- ClinicalTrials.gov ID
- NCT00958347
- Acronym / sponsor ID
- 01/04
- Conditions
- Arthroplasty, Replacement, Hip
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to lagging follow-up
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Stryker OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- Oct 1987
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 13 Aug 2009 (estimated)
- Results
- Posted 19 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to obtain up to 25 year post-operative data on the Omnifit Hydroxylapatite (HA) Hip System in support of the hypothesis that it is a satisfactory system for reducing implant loosening, permitting tissue bonding onto the hydroxylapatite surfaces of the implant and providing a safe, efficient, and well-functioning hip in a wide spectrum of clinical circumstances.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omnifit HA Hip Stem | Other | Device: Omnifit HA Hip StemParticipants underwent total hip replacement surgery using the Omnifit HA Hip Stem. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Acute femoral neck fracture.
- Non-union of femoral head and neck fractures.
- Aseptic necrosis of the femoral head.
- Osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
- Salvage of failed total hip arthroplasty.
Key exclusion criteria (7 listed)
- Active infection in or near the hip joint.
- Pathological bone conditions which would significantly compromise the ability to carry physiologic stress levels and for which bone grafting would be inappropriate (i.e. severe osteoporosis, Paget's Disease, renal osteodystrophy, etc.).
- Neuro-muscular disorders in which the potentially adverse effects on prosthesis function are not outweighed by the benefits to be gained by the patient from usage of the implant.
- Mental disorders which would compromise essential patient post-operative care.
- Skeletal immaturity.
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 |
|---|---|---|
| Omnifit HA Hip StemTotal Hip Replacement with Omnifit HA Hip Stem | Device | Omnifit HA Hip Stem |
Primary outcome
Patients Will be Evaluated for Pain, Functional Level, and Clinical Complications Utilizing the Harris Hip Score.
Time frame: 25 Years Post-Operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
William Capello, MD study chair
Indiana University Medical Center
William Jaffe, MD principal investigator
Hospital for Joint Disease/ Orthopaedic Institute
Rudolph Geesink, MD principal investigator
Trialbureau Orthopedics
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omnifit HA Hip Stem in people with Arthroplasty, Replacement, Hip, run by Stryker Orthopaedics at 4 sites in 2 countries.
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 9 inclusion and 7 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 19 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Netherlands. 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?
Yes. Results are posted in the registry (first posted 19 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patients Will be Evaluated for Pain, Functional Level, and Clinical Complications Utilizing the Harris Hip Score. (time frame: 25 Years Post-Operatively). 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 19 Aug 2014.