In Need of a Total Hip ArthroplastyNCT01943149
E-MAX 2nd Gen Vit E Poly On BIOLOX Delta Ceramic Heads
An observational study of In Need of a Total Hip Arthroplasty, run by Renovis Surgical Technologies, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to monitor outcomes of total hip arthroplasties performed with E-MAX polyethylene and BIOLOX Delta Ceramic head. Polyethylene has been used as a bearing surface in total joint replacements for half of a century. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- In Need of a Total Hip Arthroplasty
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jan 2024
- Phase
- Observational
- 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
Study population: Subjects will be patients of specified doctors specialized in orthopedic medicine with a specialty in joint replacement.
Who may be able to join
- Patient is under 65 years of age
- Patient's health status qualifies as ASA 1 or ASA 2
- Patient is willing to commit to long term follow (study duration is 10 yrs)
Who cannot join
- Allergy to any materials used in hip implant
- Unwillingness to participate in long term follow-up
- Diagnosis of inflammatory arthritis
- Simultaneous bilateral total hip arthroplasty is recommended.
- Patient's health status qualifies as ASA 3 or greater.
- Patient is over the age of 65 of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: E-MAX 2nd Generation Vitamin E Polyethylene On BIOLOX Delta Ceramic Heads
The purpose of this study is to monitor outcomes of total hip arthroplasties performed with E-MAX polyethylene and BIOLOX Delta Ceramic head. Polyethylene has been used as a bearing surface in total joint replacements for half of a century. Radiation, the most common form of sterilization, unfortunately it results in the creation of free radicals (atoms or molecules that cause chemical reactions with other substances) within the materials which cause the breakdown of the polyethylene. Second generation antioxidant polyethylene, Renovis E-MAX, mechanically blends in Vitamin E as an antioxidant. This helps eliminate free radicals while maintaining mechanical strength. The theory is that E-MAX will be a safe and long lasting bearing surface in total hip arthroplasty that meets or exceeds current wear rates after being placed in a patient.
- Conditions
- In Need of a Total Hip Arthroplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
E-Max liner wear rate
This measure's purpose it to look at the longevity of our product. Radiographs will be taken at standard checkpoints over the course of 10 years. Radiographic analysis will be done to assess wear rates of the E-Max liner over the course of the 10 year study. Wear rates will then be compared to other products that have already been studied and published in hopes of finding that E-Max's wear rates are at least as good if not better than comparative products on the market.
Measured: Change from baseline to 10 years post-operative
Secondary outcomes (1)
Patient Function and Mobility
This measure will assess patient function and mobility preoperatively and compare this at standard checkpoints over 10 years post-operatively. This will be done through use of the Harris Hip Score and UCLA Functional Assessment with the hope of seeing improvement in both over the course of time.
Measured: Change from Pre-operative to 10 years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startJan 2014
- Primary completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In Need of a Total Hip ArthroplastyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renovis Surgical Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943149
- Sponsor's protocol ID
- HIP-001
- Status last verified
- Oct 2015
- First submitted
- 6 Sep 2013
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-MAX 2nd Generation Vitamin E Polyethylene On BIOLOX Delta Ceramic Heads
- ClinicalTrials.gov ID
- NCT01943149
- Acronym / sponsor ID
- HIP-001
- Conditions
- In Need of a Total Hip Arthroplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Renovis Surgical Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Jan 2024 (estimated)
- First posted
- 16 Sep 2013 (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 this study is to monitor outcomes of total hip arthroplasties performed with E-MAX polyethylene and BIOLOX Delta Ceramic head. Polyethylene has been used as a bearing surface in total joint replacements for half of a century. Radiation, the most common form of sterilization, unfortunately it results in the creation of free radicals (atoms or molecules that cause chemical reactions with other substances) within the materials which cause the breakdown of the polyethylene. Second generation antioxidant polyethylene, Renovis E-MAX, mechanically blends in Vitamin E as an antioxidant. This helps eliminate free radicals while maintaining mechanical strength. The theory is that E-MAX will be a safe and long lasting bearing surface in total hip arthroplasty that meets or exceeds current wear rates after being placed in a patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be patients of specified doctors specialized in orthopedic medicine with a specialty in joint replacement.
Key inclusion criteria (3 listed)
- Patient is under 65 years of age
- Patient's health status qualifies as ASA 1 or ASA 2
- Patient is willing to commit to long term follow (study duration is 10 yrs)
Key exclusion criteria (6 listed)
- Allergy to any materials used in hip implant
- Unwillingness to participate in long term follow-up
- Diagnosis of inflammatory arthritis
- Simultaneous bilateral total hip arthroplasty is recommended.
- Patient's health status qualifies as ASA 3 or greater.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
E-Max liner wear rate
Time frame: Change from baseline to 10 years post-operative
This measure's purpose it to look at the longevity of our product. Radiographs will be taken at standard checkpoints over the course of 10 years. Radiographic analysis will be done to assess wear rates of the E-Max liner over the course of the 10 year study. Wear rates will then be compared to other products that have already been studied and published in hopes of finding that E-Max's wear rates are at least as good if not better than comparative products on the market.
1 secondary outcome
Patient Function and Mobility
Time frame: Change from Pre-operative to 10 years post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of In Need of a Total Hip Arthroplasty, run by Renovis Surgical Technologies, Inc. at 1 site 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 28 Oct 2015. 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 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.
Are results available for this study?
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?
E-Max liner wear rate (time frame: Change from baseline to 10 years post-operative). 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 28 Oct 2015.