Osteoarthritis, HipNCT02196792
Assessment of Polyethylene Wear, Migration and Clinical Outcome in Total Hip Replacement
A study testing E-Poly liner, ArComXL liner and 32 mm femoral head in people with Osteoarthritis, Hip and Osteoarthritis, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The objective of the study is to investigate head penetration, cup migration, and clinical outcome in total hip replacements using a factorial design. Treatment groups are E-Poly versus ArComXL liners, and 36 mm versus 32 mm head size. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Osteoarthritis, Hip, Osteoarthritis
- What is being tested?
- E-Poly liner, ArComXL liner and 32 mm femoral head
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2009to 1 May 2030
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary idiopathic arthritis,
- Eligible for uncemented total hip arthroplasty
- 40 to70 years of age,
- Cup size of 54mm and above
Who cannot join
- Anteversion where non-standard stem can be used,
- Dysplasia (Center-edge angle of Wiberg < 20°),
- Malignant condition
- Prior radiotherapy
- Physical or psychological condition that renders it impossible for the patient to take part in our usual rehabilitation programme (as stated in the department's standard operation procedure),
- Complications during surgery (requiring screws in shell or femoral cerclage)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Joseph Abdalla Nommesen El-Sahoury
Odense C, Region Syddanmark, 5000
About this study
Official title: Assessment of Polyethylene Wear, Migration and Clinical Outcome in Total Hip Replacement - A Prospective Randomized Control Trial
The objective of the study is to investigate head penetration, cup migration, and clinical outcome in total hip replacements using a factorial design. Treatment groups are E-Poly versus ArComXL liners, and 36 mm versus 32 mm head size.
- Conditions
- Osteoarthritis, Hip, Osteoarthritis
- Being tested
- E-Poly liner, ArComXL liner, 32 mm femoral head, 36 mm femoral head
- Keywords
- Joint Diseases, Musculoskeletal Diseases, radiostereometric analysis, Total hip arthroplasty
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis, Joint Diseases, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-Poly linerDevice
E-Poly liner with a titanium cup
ArComXL linerDevice
ArComXL liner with a titanium cup
32 mm femoral headDevice
Stem with a 32 mm CoCr femoral head
36 mm femoral headDevice
Stem with a 36 mm CoCr femoral head
| Study group | Role | What they receive |
|---|---|---|
| E-Poly/32 mm | Active comparator | E-Poly polyethylene liner in a titanium cup with a stem with 32 mm cobalt-chromium (CoCr) femoral head. Receives: Device: E-Poly liner; Device: 32 mm femoral head |
| E-Poly/36 mm | Active comparator | E-Poly polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head. Receives: Device: E-Poly liner; Device: 36 mm femoral head |
| ArComXL/32 mm | Active comparator | ArComXL polyethylene liner in a titanium cup with a stem with 32 mm CoCr femoral head. Receives: Device: ArComXL liner; Device: 32 mm femoral head |
| ArComXL/36 mm | Active comparator | ArComXL polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head. Receives: Device: ArComXL liner; Device: 36 mm femoral head |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean head penetration from baseline to 5 year follow-up
Mean head penetration assessed using röntgen steregrammetry analysis (RSA) from baseline to 5 year follow-up
Measured: From baseline to 5 years
Secondary outcomes (2)
Mean cup migration form baseline to 5 year follow-up
Mean cup migration assessed using RSA from baseline to 5 year follow-up
Measured: From baseline to 5 years
Mean change in clinical outcome score from baseline to 5 year follow-up
Mean change in patient-reported hip function (Harris Hip Score), quality of life (EQ-5D and SF-36), and patient activity (UCLA Activity Score).
Measured: From baseline to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study start1 May 2009
- Primary completion1 May 2015
- Study completion1 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- More trials run by Odense University 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
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Principal investigator, Joseph Abdalla Nommesen El-Sahoury, Odense University Hospital
- Investigators
- Joseph Abdalla N. El-Sahoury, BSc.med, Principal investigator, OUH Den Ortopædkirurgiske ForskningsenhedMing Ding, Professor MD, Study director, Odense University Hospital, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196792
- Sponsor's protocol ID
- project-ID S-20080151
- Status last verified
- Jun 2022
- First submitted
- 14 Jul 2014
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Polyethylene Wear, Migration and Clinical Outcome in Total Hip Replacement - A Prospective Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02196792
- Acronym / sponsor ID
- project-ID S-20080151
- Conditions
- Osteoarthritis, Hip, Osteoarthritis
- Keywords
- Joint Diseases, Musculoskeletal Diseases, radiostereometric analysis, Total hip arthroplasty
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- 1 May 2009
- Primary completion
- 1 May 2015 (actual)
- Study completion
- 1 May 2030 (estimated)
- First posted
- 22 Jul 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.
The objective of the study is to investigate head penetration, cup migration, and clinical outcome in total hip replacements using a factorial design. Treatment groups are E-Poly versus ArComXL liners, and 36 mm versus 32 mm head size.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| E-Poly/32 mm | Active comparator | Device: E-Poly liner, Device: 32 mm femoral headE-Poly polyethylene liner in a titanium cup with a stem with 32 mm cobalt-chromium (CoCr) femoral head. |
| E-Poly/36 mm | Active comparator | Device: E-Poly liner, Device: 36 mm femoral headE-Poly polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head. |
| ArComXL/32 mm | Active comparator | Device: ArComXL liner, Device: 32 mm femoral headArComXL polyethylene liner in a titanium cup with a stem with 32 mm CoCr femoral head. |
| ArComXL/36 mm | Active comparator | Device: ArComXL liner, Device: 36 mm femoral headArComXL polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary idiopathic arthritis,
- Eligible for uncemented total hip arthroplasty
- 40 to70 years of age,
- Cup size of 54mm and above
Key exclusion criteria (6 listed)
- Anteversion where non-standard stem can be used,
- Dysplasia (Center-edge angle of Wiberg < 20°),
- Malignant condition
- Prior radiotherapy
- Physical or psychological condition that renders it impossible for the patient to take part in our usual rehabilitation programme (as stated in the department's standard operation procedure),
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 |
|---|---|---|
| E-Poly linerE-Poly liner with a titanium cup | Device | E-Poly/32 mm, E-Poly/36 mm |
| ArComXL linerArComXL liner with a titanium cup | Device | ArComXL/32 mm, ArComXL/36 mm |
| 32 mm femoral headStem with a 32 mm CoCr femoral head | Device | ArComXL/32 mm, E-Poly/32 mm |
| 36 mm femoral headStem with a 36 mm CoCr femoral head | Device | ArComXL/36 mm, E-Poly/36 mm |
Primary outcome
Mean head penetration from baseline to 5 year follow-up
Time frame: From baseline to 5 years
Mean head penetration assessed using röntgen steregrammetry analysis (RSA) from baseline to 5 year follow-up
2 secondary outcomes
Mean cup migration form baseline to 5 year follow-up
Time frame: From baseline to 5 years
Mean change in clinical outcome score from baseline to 5 year follow-up
Time frame: From baseline to 5 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 21 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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.
Joseph Abdalla N. El-Sahoury, BSc.med principal investigator
OUH Den Ortopædkirurgiske Forskningsenhed
Ming Ding, Professor MD study director
Odense University Hospital, University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-Poly liner, ArComXL liner and 32 mm femoral head in people with Osteoarthritis, Hip and Osteoarthritis, run by Odense University Hospital at 1 site in Denmark.
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 4 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 21 Jun 2022. 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 Denmark. 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?
Mean head penetration from baseline to 5 year follow-up (time frame: From baseline to 5 years). 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 21 Jun 2022.