Total Hip ArthroplastyE1-hipNCT02254980
Migration and Head Penetration of Vitamin-E Diffused Cemented Polyethylene Cup in Total Hip Arthroplasty
A study testing Vitamin-E diffused polyethylene acetabular component and Standard polyethylene acetabular component in people with Total Hip Arthroplasty, run by Danderyd Hospital at 1 site in Sweden.
Trial summary
In vitro, Vitamin-E diffused, highly cross-linked polyethylene (PE) have been shown to have superior wear resistance and improved mechanical properties as compared to that of standard highly cross-linked PE. There are as of yet no published studies with vitamin-E diffused PE although several trials are ongoing. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- Vitamin-E diffused polyethylene acetabular component and Standard polyethylene acetabular component
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2013to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary osteoarthritis of the hip
- Willingness and ability to follow study-protocol
Who cannot join
- Inflammatory arthritis or secondary osteoarthritis.
- Type C (stove pipe) femur
- Abnormal femoral or pelvic anatomy after hip dysplasia, not suitable for implantation of components
- Treatment with bisphosphonates, cortisol or cytostatic drugs 6 months prior to surgery
- Ongoing oestrogen treatment
- Not suited for the study for other reason (surgeons preference)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Migration and Head Penetration of Vitamin-E Diffused Cemented Polyethylene Cup Compared to Standard Cemented Cup in Total Hip Arthroplasty. A Randomized, Single-blinded, Clinical Trial
In vitro, Vitamin-E diffused, highly cross-linked polyethylene (PE) have been shown to have superior wear resistance and improved mechanical properties as compared to that of standard highly cross-linked PE. There are as of yet no published studies with vitamin-E diffused PE although several trials are ongoing. All of these trials use uncemented acetabular cups intended for biological fixation. In many countries the standard fixation method for the acetabular component is bone-cement. The Vitamin-E used in implants is alfa-tocopherol, a lipid-soluble antioxidant with oily consistency; theoretically affecting cemented fixation when used in acetabular components. The aim of the study is to compare migration, linear wear and clinical results between two types of cemented acetabular cups.
- Conditions
- Total Hip Arthroplasty
- Being tested
- Vitamin-E diffused polyethylene acetabular component, Standard polyethylene acetabular component
- Keywords
- Total hip arthroplasty, Cemented acetabular cup, Vitamin-E, Radiostereometry, Fixation of cemented acetabular component in total hip arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin-E diffused polyethylene acetabular componentDevice
Patients will undergo total hip arthroplasty using a cemented acetabular component diffused with Vitamin-E
Standard polyethylene acetabular componentDevice
Patients will undergo total hip arthroplasty using a standard cemented acetabular component
| Study group | Role | What they receive |
|---|---|---|
| Vitamin-E group | Experimental | Vitamin-E diffused polyethylene Receives: Device: Vitamin-E diffused polyethylene acetabular component |
| Control group | Active comparator | Standard polyethylene Receives: Device: Standard polyethylene acetabular component |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cup migration
The primary outcome measure is migration of the cup at 2 years measured with radiostereometry (RSA) as proximal migration.
Measured: 2 years
Secondary outcomes (7)
Linear wear
Linear head penetration measured with RSA at 2 years
Measured: 2 years
Linear wear
Linear head penetration measured with RSA at 4 years
Measured: 4 years
Osteolysis
Development of radiolucent lines between bone and cement around the cup.
Measured: 10 years
Osteolysis
Development of radiolucent lines between bone and cement around the cup.
Measured: 2 years
Functional outcome
Hip function measured with Harris hip score
Measured: 2 years
Complication rate
All hip-related complications and revision of implants
Measured: 10 years
Cup migration total
Migration of the cup at 2 years measured with radiostereometry (RSA) as maximum total point motion (MTPM).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startFeb 2013
- Primary completionOct 2019 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Principal investigator, Olof Skoldenberg, Danderyd Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02254980
- Sponsor's protocol ID
- E1-H
- Acronym
- E1-hip
- Status last verified
- Feb 2019
- First submitted
- 30 Sep 2014
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Kramer E, Sandberg O, Bruggemann A, Hailer NP, Skoldenberg O, Broden C. CT-Based Radiostereometric Analysis: A Promising Alternative to Conventional Radiostereometric Analysis in Determining Polyethylene Wear in Total Hip Arthroplasty. Adv Orthop. 2026 Sep 16;2026:8544470. doi: 10.1155/aort/8544470. eCollection 2026.
PubMed 42756585Skoldenberg O, Rysinska A, Chammout G, Salemyr M, Muren O, Boden H, Eisler T. Migration and head penetration of Vitamin-E diffused cemented polyethylene cup compared to standard cemented cup in total hip arthroplasty: study protocol for a randomised, double-blind, controlled trial (E1 HIP). BMJ Open. 2016 Jul 7;6(7):e010781. doi: 10.1136/bmjopen-2015-010781.
PubMed 27388352
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Migration and Head Penetration of Vitamin-E Diffused Cemented Polyethylene Cup Compared to Standard Cemented Cup in Total Hip Arthroplasty. A Randomized, Single-blinded, Clinical Trial
- ClinicalTrials.gov ID
- NCT02254980
- Acronym / sponsor ID
- E1-hip / E1-H
- Conditions
- Total Hip Arthroplasty
- Keywords
- Total hip arthroplasty, Cemented acetabular cup, Vitamin-E, Radiostereometry, Fixation of cemented acetabular component in total hip arthroplasty
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- Feb 2013
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 2 Oct 2014 (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.
In vitro, Vitamin-E diffused, highly cross-linked polyethylene (PE) have been shown to have superior wear resistance and improved mechanical properties as compared to that of standard highly cross-linked PE. There are as of yet no published studies with vitamin-E diffused PE although several trials are ongoing. All of these trials use uncemented acetabular cups intended for biological fixation. In many countries the standard fixation method for the acetabular component is bone-cement. The Vitamin-E used in implants is alfa-tocopherol, a lipid-soluble antioxidant with oily consistency; theoretically affecting cemented fixation when used in acetabular components. The aim of the study is to compare migration, linear wear and clinical results between two types of cemented acetabular cups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin-E group | Experimental | Device: Vitamin-E diffused polyethylene acetabular componentVitamin-E diffused polyethylene |
| Control group | Active comparator | Device: Standard polyethylene acetabular componentStandard polyethylene |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary osteoarthritis of the hip
- Willingness and ability to follow study-protocol
Key exclusion criteria (6 listed)
- Inflammatory arthritis or secondary osteoarthritis.
- Type C (stove pipe) femur
- Abnormal femoral or pelvic anatomy after hip dysplasia, not suitable for implantation of components
- Treatment with bisphosphonates, cortisol or cytostatic drugs 6 months prior to surgery
- Ongoing oestrogen treatment
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 |
|---|---|---|
| Vitamin-E diffused polyethylene acetabular componentPatients will undergo total hip arthroplasty using a cemented acetabular component diffused with Vitamin-E | Device | Vitamin-E group |
| Standard polyethylene acetabular componentPatients will undergo total hip arthroplasty using a standard cemented acetabular component | Device | Control group |
Primary outcome
Cup migration
Time frame: 2 years
The primary outcome measure is migration of the cup at 2 years measured with radiostereometry (RSA) as proximal migration.
7 secondary outcomes
Linear wear
Time frame: 2 years
Linear wear
Time frame: 4 years
Osteolysis
Time frame: 10 years
Osteolysis
Time frame: 2 years
Functional outcome
Time frame: 2 years
Complication rate
Time frame: 10 years
Cup migration total
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
- Derived from this study: PubMed 42756585Kramer E, Sandberg O, Bruggemann A, Hailer NP, Skoldenberg O, Broden C. CT-Based Radiostereometric Analysis: A Promising Alternative to Conventional Radiostereometric Analysis in Determining Polyethylene Wear in Total Hip Arthroplasty. Adv Orthop. 2026 Sep 16;2026:8544470. doi: 10.1155/aort/8544470. eCollection 2026.
- Derived from this study: PubMed 27388352Skoldenberg O, Rysinska A, Chammout G, Salemyr M, Muren O, Boden H, Eisler T. Migration and head penetration of Vitamin-E diffused cemented polyethylene cup compared to standard cemented cup in total hip arthroplasty: study protocol for a randomised, double-blind, controlled trial (E1 HIP). BMJ Open. 2016 Jul 7;6(7):e010781. doi: 10.1136/bmjopen-2015-010781.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin-E diffused polyethylene acetabular component and Standard polyethylene acetabular component in people with Total Hip Arthroplasty, run by Danderyd Hospital at 1 site in Sweden.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 7 Feb 2019. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
Cup migration (time frame: 2 years). 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 NCT02254980, which also lists 2 linked publications.
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 7 Feb 2019.