Hip OsteoarthritisDePuy RSA RCTNCT02696395
RSA-measured in Vivo Migration and Micromotion in the DePuy Tri-Lock, Corail and Deltamotion Hip Replacement Components
A study testing DePuy Tri-Lock® femoral stem + Deltamotion® acetabular component and DePuy Corail® femoral stem + Deltamotion® acetabular component in people with Hip Osteoarthritis, run by University of Oxford at 1 site in United Kingdom.
Trial summary
Hip replacements are being performed on an increasingly active population, who are likely to wear their implants out prematurely. New hip replacements have been devised to minimise the risk of failure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- DePuy Tri-Lock® femoral stem + Deltamotion® acetabular component and DePuy Corail® femoral stem + Deltamotion® acetabular component
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2015to Dec 2019
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged between 18 and 65 years and men aged between 18 and 70 years.
- Participant is willing and able to give informed consent for participation in the study.
- Diagnosed with hip osteoarthritis.
- Able (in the Investigators opinion) and willing to comply with all study requirements.
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Who cannot join
- Any patients with an inflammatory arthropathy, osteoporosis or deformities of the proximal femur.
- Patients who have significant co-morbidities that would make follow-up difficult or uncomfortable.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Nuffield Orthopaedic Centre
Oxford, OX3 7HE
Sion Glyn-Jones, MA, DPhil, FRCS, +441865737839, sion.glyn-jones@ndorms.ox.ac.uk
John Broomfield, MBChB, MSc, MRCS, +441865223422, john.broomfield@ndorms.ox.ac.uk
About this study
Official title: RSA-measured in Vivo Migration and Micromotion in the DePuy Tri-lock, Corail and Deltamotion Hip Replacement Components: a Single-blinded Randomised Control Trial
Hip replacements are being performed on an increasingly active population, who are likely to wear their implants out prematurely. New hip replacements have been devised to minimise the risk of failure. DePuy RSA RCT is a randomised controlled trial designed to compare the performance of two established types of hip replacements using Corail and Tri-Lock stems along with Deltamotion acetabular component. The primary objective of the trial is to compare the long term stability of these two devices.To do this, the study will use an advanced 3D Xray technique to detect migration of the components at 3 years. The study will also measure micromotion of Corail, Tri-Lock and Deltamotion components, patient reported outcome measures and change in bone density.This study is being conducted at a single site, at the Nuffield Orthopaedic Centre, Oxford.
- Conditions
- Hip Osteoarthritis
- Being tested
- DePuy Tri-Lock® femoral stem + Deltamotion® acetabular component, DePuy Corail® femoral stem + Deltamotion® acetabular component
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DePuy Tri-Lock® femoral stem + Deltamotion® acetabular componentDevice
DePuy Corail® femoral stem + Deltamotion® acetabular componentDevice
| Study group | Role | What they receive |
|---|---|---|
| DePuy Tri-Lock® | Active comparator | Total hip replacement with DePuy Tri-Lock® femoral stem and Deltamotion® acetabular component. The surgery will be conducted using a postero-lateral approach followed by post operative rehabilitation as per standard care. Receives: Device: DePuy Tri-Lock® femoral stem + Deltamotion® acetabular component |
| DePuy Corail® | Active comparator | Total hip replacement with DePuy Corail® femoral stem and Deltamotion® acetabular component. The surgery will be conducted using a postero-lateral approach followed by post operative rehabilitation as per standard care. Receives: Device: DePuy Corail® femoral stem + Deltamotion® acetabular component |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean total Radio Stereometric Analysis (RSA) measured migration of DePuy Tri-Lock® femoral stem vs DePuy Corail® femoral stem (mm/yr).
Measured: 3 years
Secondary outcomes (4)
Dynamically Inducible Micromotion (DIMM) of DePuy Corail®, Tri-Lock® and Deltamotion® components (mm/yr).
Measured: 3 years
Radio Stereometric Analysis (RSA) measured migration of DePuy Deltamotion® acetabular component
Measured: 3 years
Change in Oxford Hip Score (OHS) at three years.
Measured: 3 years
Change in bone density using Dual Energy X-Ray Absorptiometry (DEXA) scan at 12 months.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startJul 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy International
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696395
- Sponsor's protocol ID
- DePuy RSA RCT
- Acronym
- DePuy RSA RCT
- Status last verified
- Feb 2016
- First submitted
- 16 Nov 2015
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RSA-measured in Vivo Migration and Micromotion in the DePuy Tri-lock, Corail and Deltamotion Hip Replacement Components: a Single-blinded Randomised Control Trial
- ClinicalTrials.gov ID
- NCT02696395
- Acronym / sponsor ID
- DePuy RSA RCT / DePuy RSA RCT
- Conditions
- Hip Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- DePuy International
- Study start
- Jul 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 2 Mar 2016 (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.
Hip replacements are being performed on an increasingly active population, who are likely to wear their implants out prematurely. New hip replacements have been devised to minimise the risk of failure. DePuy RSA RCT is a randomised controlled trial designed to compare the performance of two established types of hip replacements using Corail and Tri-Lock stems along with Deltamotion acetabular component. The primary objective of the trial is to compare the long term stability of these two devices.To do this, the study will use an advanced 3D Xray technique to detect migration of the components at 3 years. The study will also measure micromotion of Corail, Tri-Lock and Deltamotion components, patient reported outcome measures and change in bone density.This study is being conducted at a single site, at the Nuffield Orthopaedic Centre, Oxford.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DePuy Tri-Lock® | Active comparator | Device: DePuy Tri-Lock® femoral stem + Deltamotion® acetabular componentTotal hip replacement with DePuy Tri-Lock® femoral stem and Deltamotion® acetabular component. The surgery will be conducted using a postero-lateral approach followed by post operative rehabilitation as per standard care. |
| DePuy Corail® | Active comparator | Device: DePuy Corail® femoral stem + Deltamotion® acetabular componentTotal hip replacement with DePuy Corail® femoral stem and Deltamotion® acetabular component. The surgery will be conducted using a postero-lateral approach followed by post operative rehabilitation as per standard care. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women aged between 18 and 65 years and men aged between 18 and 70 years.
Key exclusion criteria (3 listed)
- Any patients with an inflammatory arthropathy, osteoporosis or deformities of the proximal femur.
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 |
|---|---|---|
| DePuy Tri-Lock® femoral stem + Deltamotion® acetabular component | Device | DePuy Tri-Lock® |
| DePuy Corail® femoral stem + Deltamotion® acetabular component | Device | DePuy Corail® |
Primary outcome
Mean total Radio Stereometric Analysis (RSA) measured migration of DePuy Tri-Lock® femoral stem vs DePuy Corail® femoral stem (mm/yr).
Time frame: 3 years
4 secondary outcomes
Dynamically Inducible Micromotion (DIMM) of DePuy Corail®, Tri-Lock® and Deltamotion® components (mm/yr).
Time frame: 3 years
Radio Stereometric Analysis (RSA) measured migration of DePuy Deltamotion® acetabular component
Time frame: 3 years
Change in Oxford Hip Score (OHS) at three years.
Time frame: 3 years
Change in bone density using Dual Energy X-Ray Absorptiometry (DEXA) scan at 12 months.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DePuy Tri-Lock® femoral stem + Deltamotion® acetabular component and DePuy Corail® femoral stem + Deltamotion® acetabular component in people with Hip Osteoarthritis, run by University of Oxford at 1 site in United Kingdom.
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 5 inclusion and 3 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 2 Mar 2016. 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 Kingdom. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean total Radio Stereometric Analysis (RSA) measured migration of DePuy Tri-Lock® femoral stem vs DePuy Corail® femoral stem (mm/yr). (time frame: 3 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 2 Mar 2016.