Advanced Hip DiseasePhase 3NCT00746616
Durom(R) Hip Resurfacing System Multicenter Trial
A Phase 3 study testing Durom Hip Resurfacing System in people with Advanced Hip Disease, run by Zimmer Biomet at 5 sites in United States.
Trial summary
The purpose of the study is to gather clinical information on the safety and efficacy of the resurfacing devices in the young, active patient with advanced hip disease. Study enrollment has been temporarily suspended due to a change in the surgical technique. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Advanced Hip Disease
- What is being tested?
- Durom Hip Resurfacing System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2007to Mar 2011
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient selection without bias to race or gender
- Patient is greater than or equal to 18 and less than or equal to 65 years of age.
- Female patients only:
- actively practicing a contraceptive method, or
- surgically sterilized, or
- post-menopausal
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- Pre-operative Harris Hip Score less than or equal to 70.
- Primary surgical hip candidate, suffering from hip pain and/or disability due to degenerative joint disease (inflammatory or non-inflammatory), based on physical examination and history, including the following diagnosis:
- non-inflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis or osteoarthritis
- inflammatory joint disease (IJD), e.g. rheumatoid arthritis
- Patient is willing and able to cooperate in prescribed post-operative therapy.
- Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
- Patient has participated in the Informed Consent process and has signed and IRB approved Informed Consent.
Who cannot join
- Patient with an acute, chronic, local or systemic infection.
- Patient who is skeletally immature.
- Patient with a severe muscular, neural or vascular disease that endangers the involved extremity.
- Patient with an insufficient acetabular or femoral bone stock in which good anchorage of the implants are unlikely or impossible, including but not limited to:
- patient with severe osteopenia
- patients with a family history of severe osteoporosis or osteopenia
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- patients with osteonecrosis or avascular necrosis (AVN) with > 50% involvement of the femoral head (regardless of FICAT grade)
- patients with multiple cysts of the femoral head > 1cm
- Patient with total or partial absence of the muscular of ligamentous apparatus.
- Patient has known moderate to severe renal insufficiency.
- Patient with a known clinical condition which may interfere with patient outcome, including but not limited to:
- immuno-compromised conditions (AIDS),
- organ transplant recipient,
- high doses of corticosteroids etc
- Patient who is severely overweight (BMI >40)
- Operative (ipsilateral) Hip: Patient has a total prosthetic hip replacement device, surface arthroplasty or endoprosthesis.
- Contralateral Hip: Patient has had hip replacement, surface arthroplasty or endoprosthesis, within the past 12 months, unless already enrolled in this investigational study.
- Patient who is:
- a prisoner
- mentally incompetent
- a known alcohol or drug abuser
- anticipated to be non-compliant
- Patient who has participated in a study of any other investigational device (drug, device or biologic) within the past 12 months. Exception: previous enrollment in the Durom Hip Resurfacing System clinical study.
- Patient has a known allergy to one of the constituents of the implant, e.g. cobalt, chromium, nickel, etc.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Syracuse Orthopedic Specialists
De Witt, New York, 13214
Colorado Joint Replacement
Denver, Colorado, 80210
Texas Hip and Knee
Fort Worth, Texas, 76104
PENN Orthopedics
Philadelphia, Pennsylvania, 19107
Eastern Oklahoma Orthopedic Center
Tulsa, Oklahoma, 74136
About this study
The purpose of the study is to gather clinical information on the safety and efficacy of the resurfacing devices in the young, active patient with advanced hip disease. Study enrollment has been temporarily suspended due to a change in the surgical technique.
Read the detailed description
Safety will be evaluated based on the frequency and incidence of any device related adverse events or unanticipated adverse device events. The efficacy will be measured by comparing the overall functional performance based on the Harris Hip Score, implant survivorship, and radiographic parameters, including radiolucencies, osteolysis, stem subsidence, cup migration, and change in cup angle and a change in the femoral shaft angle.
- Conditions
- Advanced Hip Disease
- Being tested
- Durom Hip Resurfacing System
- Keywords
- Total Hip Arthroplasty,, Acetabular Cup,, Hip Resurfacing, Young,, active, patients
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Durom Hip Resurfacing SystemDevice
Also called Hip Reserfacing
Hip resurfacing devices in the young, active patient with advanced hip disease instead of traditional total hip arthroplasty.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Hip resurfacing devices in the young, active patient with advanced hip disease instead of traditional total hip arthroplasty. Receives: Device: Durom Hip Resurfacing System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Survival
Measured: All post-op visits until last patient enrolled reaches 2 year follow-up
Secondary outcomes (1)
Efficacy
Measured: 6 month post-op and annually until last patient reaches 2 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2008 (estimated)
- Study startJun 2007
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hip DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746616
- Sponsor's protocol ID
- 06-100
- Other IDs
- G060120/S6
- Status last verified
- Apr 2013
- First submitted
- 2 Sep 2008
- Last updated
- 10 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Durom(R) Hip Resurfacing System Multicenter Trial
- ClinicalTrials.gov ID
- NCT00746616
- Acronym / sponsor ID
- 06-100
- Conditions
- Advanced Hip Disease
- Keywords
- Total Hip Arthroplasty,, Acetabular Cup,, Hip Resurfacing, Young,, active, patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 4 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.
The purpose of the study is to gather clinical information on the safety and efficacy of the resurfacing devices in the young, active patient with advanced hip disease. Study enrollment has been temporarily suspended due to a change in the surgical technique.
Detailed description
Safety will be evaluated based on the frequency and incidence of any device related adverse events or unanticipated adverse device events. The efficacy will be measured by comparing the overall functional performance based on the Harris Hip Score, implant survivorship, and radiographic parameters, including radiolucencies, osteolysis, stem subsidence, cup migration, and change in cup angle and a change in the femoral shaft angle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Durom Hip Resurfacing SystemHip resurfacing devices in the young, active patient with advanced hip disease instead of traditional total hip arthroplasty. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patient selection without bias to race or gender
- Patient is greater than or equal to 18 and less than or equal to 65 years of age.
- Female patients only:
- Pre-operative Harris Hip Score less than or equal to 70.
- Primary surgical hip candidate, suffering from hip pain and/or disability due to degenerative joint disease (inflammatory or non-inflammatory), based on physical examination and history, including the following diagnosis:
Key exclusion criteria (24 listed)
- Patient with an acute, chronic, local or systemic infection.
- Patient who is skeletally immature.
- Patient with a severe muscular, neural or vascular disease that endangers the involved extremity.
- Patient with an insufficient acetabular or femoral bone stock in which good anchorage of the implants are unlikely or impossible, including but not limited to:
- Patient with total or partial absence of the muscular of ligamentous apparatus.
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 |
|---|---|---|
| Durom Hip Resurfacing SystemAlso: Hip ReserfacingHip resurfacing devices in the young, active patient with advanced hip disease instead of traditional total hip arthroplasty. | Device | 1 |
Primary outcome
Device Survival
Time frame: All post-op visits until last patient enrolled reaches 2 year follow-up
1 secondary outcome
Efficacy
Time frame: 6 month post-op and annually until last patient reaches 2 year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Durom Hip Resurfacing System in people with Advanced Hip Disease, run by Zimmer Biomet at 5 sites in United States.
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 13 inclusion and 24 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: finished, as of the sponsor's last update on 10 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Device Survival (time frame: All post-op visits until last patient enrolled reaches 2 year follow-up). 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 10 Apr 2013.