Osteoarthritis of HipNCT00545285
Long-Term Multi-center Evaluation of E-Poly and Regenerex
A study testing Total Hip Arthroplasty in people with Osteoarthritis of Hip and Traumatic Arthritis of Hip, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
There are two distinct aims of this study: 1. This prospective study is designed to document the long-term (10-year) radiographic and clinical outcomes of a new type of highly cross-linked polyethylene liner which contains vitamin E as an anti-oxidant, (E-Poly), in a group of primary total hip arthroplasty subjects. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Osteoarthritis of Hip, Traumatic Arthritis of Hip
- What is being tested?
- Total Hip Arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to May 2023
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects requiring primary total hip replacement
- Subjects with diagnosis of osteoarthritis or traumatic arthritis
- Subjects who demonstrate the ability to return for follow-up for the next 10 years
Who cannot join
- Subjects with limited life span
- Subjects with difficulty in comprehending study protocol for any reason.
- Subjects with inflammatory disease, previous infection or those requiring revision hip surgery.
- Subjects with avascular necrosis
- Subjects whose bony structures are so small that a femoral head less than 32mm in diameter must be used.
- Subjects whose bony structure deviates substantially from the general norm sufficiently to require non-standard techniques and non-standard implants. Specific examples of these are total dislocation of the hip, severe coxa vera deformity, severe forms of multiple epiphyseal dysplasia
- Subjects with complex disease entities which significantly increase the risks of the surgery such as any major platelet abnormality, hematological disorder, positive for HIV or any other major medical complication which substantially reduces longevity.
- Female subjects that are pregnant or who may suspect they are pregnant or who plan to become pregnant while participating in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Long-Term Multi-center Evaluation of E-Poly and Regenerex Cementless Acetabular Components: Clinical and Radiographic Outcomes
There are two distinct aims of this study:
- This prospective study is designed to document the long-term (10-year) radiographic and clinical outcomes of a new type of highly cross-linked polyethylene liner which contains vitamin E as an anti-oxidant, (E-Poly), in a group of primary total hip arthroplasty subjects. The clinical outcome of E-Poly will be compared to a group of subjects receiving Arcom XL polyethylene.
- This study is also designed to document the long-term (10-year) radiographic and clinical outcomes of a new cementless acetabular component having a titanium porous surface (Regenerex). The clinical outcome of this new FDA cleared device will be compared a group of subjects receiving an acetabular component having a plasma sprayed surface.
- Conditions
- Osteoarthritis of Hip, Traumatic Arthritis of Hip
- Being tested
- Total Hip Arthroplasty
- Keywords
- clinical outcomes, radiographic outcomes, total hip arthroplasty, survivorship
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip ArthroplastyProcedure or surgery
Surgical implantation of specific hip replacement components for treatment of osteoarthritis
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Total hip Arthroplasty E-Poly™ liner in a titanium plasma sprayed RingLoc® shell Receives: Procedure: Total Hip Arthroplasty |
| 2 | Active comparator | Total hip Arthroplasty ArcomXL® polyethylene liner in a titanium plasma sprayed RingLoc® shell Receives: Procedure: Total Hip Arthroplasty |
| 3 | Active comparator | Total hip Arthroplasty E-Poly™ liner with Regenerex Ringloc +™ shell Receives: Procedure: Total Hip Arthroplasty |
| 4 | Active comparator | Total hip Arthroplasty ArcomXL® polyethylene liner with Regenerex Ringloc +™ shell Receives: Procedure: Total Hip Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship: length of time implant remains without revision
Measured: Evaluated at 1,3,5,7 ,10th year over 10 years
Complications and Adverse Events
Measured: Evaluated at 1,3,5,7 ,10th year over 10 years
Incidence of radiolucencies (acetabular component)
Measured: Evaluated at 1,3,5,7 ,10th year over 10 years
Patient administered Outcome Survey scores
Measured: Evaluated at 1,3,5,7 ,10th year over 10 years
Polyethylene wear rates from AP radiographs
Measured: Evaluated at 1,3,5,7 ,10th year over 10 years
Secondary outcomes (4)
Survivorship in subcategories of infection, aseptic loosening and other
Measured: 1,3,5,7,10 yr over 10 years
Subcategories of the outcome scores regarding pain, patient satisfaction, function,general quality of life.
Measured: 1,3,5,7,10 yr over 10 years
Other outcomes that may be relevant.
Measured: 1,3,5,7,10 yr over 10 years
Retrieval analysis
Measured: 1,3,5,7,10 yr over 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of HipStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Principal investigator, Henrik Malchau, Massachusetts General Hospital
- Investigators
- Henrik Malchau, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545285
- Sponsor's protocol ID
- 2007P001955
- Status last verified
- May 2017
- First submitted
- 15 Oct 2007
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Sillesen NH, Greene ME, Nebergall AK, Huddleston JI, Emerson R, Gebuhr P, Troelsen A, Malchau H. 3-year follow-up of a long-term registry-based multicentre study on vitamin E diffused polyethylene in total hip replacement. Hip Int. 2016 Jan-Feb;26(1):97-103. doi: 10.5301/hipint.5000297. Epub 2015 Dec 11.
PubMed 26692248
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Multi-center Evaluation of E-Poly and Regenerex Cementless Acetabular Components: Clinical and Radiographic Outcomes
- ClinicalTrials.gov ID
- NCT00545285
- Acronym / sponsor ID
- 2007P001955
- Conditions
- Osteoarthritis of Hip, Traumatic Arthritis of Hip
- Keywords
- clinical outcomes, radiographic outcomes, total hip arthroplasty, survivorship
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- Nov 2007
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 17 Oct 2007 (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.
There are two distinct aims of this study:
- This prospective study is designed to document the long-term (10-year) radiographic and clinical outcomes of a new type of highly cross-linked polyethylene liner which contains vitamin E as an anti-oxidant, (E-Poly), in a group of primary total hip arthroplasty subjects. The clinical outcome of E-Poly will be compared to a group of subjects receiving Arcom XL polyethylene.
- This study is also designed to document the long-term (10-year) radiographic and clinical outcomes of a new cementless acetabular component having a titanium porous surface (Regenerex). The clinical outcome of this new FDA cleared device will be compared a group of subjects receiving an acetabular component having a plasma sprayed surface.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Total Hip ArthroplastyTotal hip Arthroplasty E-Poly™ liner in a titanium plasma sprayed RingLoc® shell |
| 2 | Active comparator | Procedure: Total Hip ArthroplastyTotal hip Arthroplasty ArcomXL® polyethylene liner in a titanium plasma sprayed RingLoc® shell |
| 3 | Active comparator | Procedure: Total Hip ArthroplastyTotal hip Arthroplasty E-Poly™ liner with Regenerex Ringloc +™ shell |
| 4 | Active comparator | Procedure: Total Hip ArthroplastyTotal hip Arthroplasty ArcomXL® polyethylene liner with Regenerex Ringloc +™ shell |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects requiring primary total hip replacement
- Subjects with diagnosis of osteoarthritis or traumatic arthritis
- Subjects who demonstrate the ability to return for follow-up for the next 10 years
Key exclusion criteria (8 listed)
- Subjects with limited life span
- Subjects with difficulty in comprehending study protocol for any reason.
- Subjects with inflammatory disease, previous infection or those requiring revision hip surgery.
- Subjects with avascular necrosis
- Subjects whose bony structures are so small that a femoral head less than 32mm in diameter must be used.
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 |
|---|---|---|
| Total Hip ArthroplastySurgical implantation of specific hip replacement components for treatment of osteoarthritis | Procedure or surgery | 1, 2, 3, 4 |
Primary outcome
Survivorship: length of time implant remains without revision
Time frame: Evaluated at 1,3,5,7 ,10th year over 10 years
Complications and Adverse Events
Time frame: Evaluated at 1,3,5,7 ,10th year over 10 years
Incidence of radiolucencies (acetabular component)
Time frame: Evaluated at 1,3,5,7 ,10th year over 10 years
Patient administered Outcome Survey scores
Time frame: Evaluated at 1,3,5,7 ,10th year over 10 years
Polyethylene wear rates from AP radiographs
Time frame: Evaluated at 1,3,5,7 ,10th year over 10 years
4 secondary outcomes
Survivorship in subcategories of infection, aseptic loosening and other
Time frame: 1,3,5,7,10 yr over 10 years
Subcategories of the outcome scores regarding pain, patient satisfaction, function,general quality of life.
Time frame: 1,3,5,7,10 yr over 10 years
Other outcomes that may be relevant.
Time frame: 1,3,5,7,10 yr over 10 years
Retrieval analysis
Time frame: 1,3,5,7,10 yr over 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- Derived from this study: PubMed 26692248Sillesen NH, Greene ME, Nebergall AK, Huddleston JI, Emerson R, Gebuhr P, Troelsen A, Malchau H. 3-year follow-up of a long-term registry-based multicentre study on vitamin E diffused polyethylene in total hip replacement. Hip Int. 2016 Jan-Feb;26(1):97-103. doi: 10.5301/hipint.5000297. Epub 2015 Dec 11.
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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.
Henrik Malchau, MD principal investigator
Massachusetts General 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 Total Hip Arthroplasty in people with Osteoarthritis of Hip and Traumatic Arthritis of Hip, run by Massachusetts General Hospital 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 8 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 3 May 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 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?
Survivorship: length of time implant remains without revision (time frame: Evaluated at 1,3,5,7 ,10th year over 10 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00545285, which also lists 1 linked publication.
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 3 May 2017; AzTrials last refreshed its copy on 1 Nov 2026.