Arthroplasties, Hip ReplacementNCT02301182
Comparison of Functional Results of ADM X3-MoP Cup (Stryker) and a CoC Cup (Zimmer) in Young Patients
A study testing ADM X3-MoP Cup and CoC Cup in people with Arthroplasties, Hip Replacement, run by University of Aarhus at 1 site in Denmark.
Trial summary
A Single-Center Randomized, Patient-Blinded, Prospective Five-Year Study to Compare the Functional Results after Insertion of ADM X3-MoP Cup (Stryker) and a CoC Cup (Zimmer) in Primary THA. 60 patients will be enrolled during a 2 year period. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Arthroplasties, Hip Replacement
- What is being tested?
- ADM X3-MoP Cup and CoC Cup
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2014to Nov 2027
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary hip osteoarthritis
- sufficient bone quality for total hip arthroplasty
- age 40 through 65 years of age
- informed and written consent
- patient can only enter the project with one hip
Who cannot join
- neuromuscular or vascular disease in the affected leg
- patients with osteoporosis
- fracture sequelae or previous extensive hip surgery
- patients with metabolic bone disease including rheumatoid arthritis
- non-Danish citizenship
- patients who do not comprehend the Danish language
Show all 14Show fewer
- senile dementia
- alcoholism and drug abuse
- major psychiatric disease
- current metastatic cancer disease and on-going treatment with radiation therapy/chemotherapy
- severe systemic disease affecting gait
- contralateral knee, hip and/or spine disease
- on-going case regarding industrial injury insurance of the hip
- patients with very poor dental status
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Center Randomized, Patient-Blinded, Prospective Five-Year Study to Compare the Functional Results After Insertion of ADM X3-MoP Cup (Stryker) and a CoC Cup (Zimmer) in Primary THA
A Single-Center Randomized, Patient-Blinded, Prospective Five-Year Study to Compare the Functional Results after Insertion of ADM X3-MoP Cup (Stryker) and a CoC Cup (Zimmer) in Primary THA. 60 patients will be enrolled during a 2 year period. At surgery tantalum beads will be inserted into predrilled holes of the polyethylene rim for assessment of motion of the large mobile poly in the ADM Trident Cup by use of RSA. Patients will be followed by functional examinations as well as PROM assessment.
Read the detailed description
With Metal-on-Metal (MoM) articulations leaving the marked the THA bearing choice for younger patients is currently debated and overall the choice stands between CoC and MoP. New HXLPE is wear-resistant and safe and clinical HXLPE wear (RSA) hardly exceed the wear measured in retrieval CoC implants. For CoC articulations stripe wear on edge loading is a reported problem leading to increased wear in examined retrieval components and CoC wear is dependent on component position. Although the risk is very small, CoC bearings are at still at risk of fracture, and functional squeaking is a complication that adversely affects the quality of life in about 1% of CoC THA patient. Dual mobility MoP cups were designed for reducing hip dislocations in older patients treated with THA after medial hip fractures. The concept provides good stability and mobility and may also be an optimal solution for younger and active patients; however, dual mobility MoP has not previously been documented for use in younger patients. The anatomical dual mobility (ADM) cup design (Stryker) is soft tissue sparing (iliopsoas tendon) potentially leading to lesser groin-pain and squeaking is not a concern. It is currently unknown if the outer-articulation of the dual mobility PE liner keeps moving over time or could impinge in the joint capsule in an undesirable position and result in unwanted edge loading and higher wear-rates. Metal ions are produced even in MoP bearings and even though in dual-articulation MoP bearings most (90%) of the motion is believed to occur between the head and liner (ceramic-polyenthylene), the metal ion levels may be higher than expected for MoP hips (large poly contact in metal shell), while expectedly there will be no metal ions in CoC THA.
- Conditions
- Arthroplasties, Hip Replacement
- Being tested
- ADM X3-MoP Cup, CoC Cup
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADM X3-MoP CupDevice
CoC CupDevice
| Study group | Role | What they receive |
|---|---|---|
| ADM X3-MoP Cup | Active comparator | THA: ADM dual-mobility hydroxyapatite coated cups with X3TM HXLPE liners on 28mm BIOLOX® delta femoral heads (Stryker) with femoral stems being 2nd generation Accolade stems of the taper lock type, proximal circumferential coated with a 50µm plasma-spray PureFix HA coating to aid the mechanical engagement in bone coating (Stryker) Receives: Device: ADM X3-MoP Cup |
| CoC Cup | Active comparator | THA: CoC BIOLOX® delta-delta large-head single-mobility cementless fiber-mesh titanium coated acetabular system from Zimmer (Zimmer TrilogyIT cup/CLS spotorno stem) with a grit-blasted osteophilic titanium alloy CLS® Spotorno femoral stems (Zimmer) that has a three-dimensional wedge shape and sharpened ribs in the proximal region Receives: Device: CoC Cup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motion analysis (accelerometer (Ax3 Axivity) based activity monitoring)
For all participants: Inertia sensors are a new technology for patient motion analysis which allows simple and fast routine clinical movement analysis and long-term activity monitoring. We will employ the newest generation of accelerometer (Ax3 Axivity) based activity monitoring (small, light, low cost, validated for orthopaedic patients also with walking aids) to count, in real life, the number of events and the duration of postures and activities. Further muscle power investigations such as by use of the legg extension power rig will be used.
Measured: 5 year
questionnaires ("the Harris Hip Score" (HHS), the Oxford Hip Score (OHS), the HOOS score, satisfaction, dislocation, and revisions)
For all participants: Pre- and postoperative clinical evaluations will be made according to "the Harris Hip Score" (HHS), the Oxford Hip Score (OHS), the HOOS score, and satisfaction, dislocations and revisions will be noted. Moreover, pre-operative rest and motion pains will be assessed by visual analogue scale scores (VAS).
Measured: 5 year
Radiography (implant migration and wear)
For all participants: Within a week following surgery a stereo x-ray is performed and this functions as the baseline for future follow-up (in this study at 1 year, 2 years and 5 years). When comparing all stereo x-rays in a patient series, implant migration with respect to a set of bone markers can be calculated in three dimensions as a function of time - similarly wear of the implant surfaces can be evaluated.Fluoroscopic stereoradiometric recordings (Dynamic RSA) can be used to assess the functional motion of implants at desired motion speeds. In this study we record the liner motion of the ADM cup with the patients in different positions that in theory stresses the motion of the liner into new positions at edge-motions. The purpose is to gain knowledge on the safety function of the implant in vivo - if the liner moves and if it positions safely like it is supposed to.
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionJun 2027 (estimated)
- Study completionNov 2027 (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 Arthroplasties, Hip ReplacementStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301182
- Sponsor's protocol ID
- VEK-44819
- Status last verified
- Nov 2026
- First submitted
- 21 Oct 2014
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Jorgensen PB, Kaptein BL, Soballe K, Jakobsen SS, Stilling M. Combined and hybrid marker models for radiostereometry assessment of polyethylene liner motion in dual mobility hip prosthesis: a proof-of-concept study. Eur Radiol Exp. 2021 Dec 15;5(1):55. doi: 10.1186/s41747-021-00253-x.
PubMed 34907467
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Randomized, Patient-Blinded, Prospective Five-Year Study to Compare the Functional Results After Insertion of ADM X3-MoP Cup (Stryker) and a CoC Cup (Zimmer) in Primary THA
- ClinicalTrials.gov ID
- NCT02301182
- Acronym / sponsor ID
- VEK-44819
- Conditions
- Arthroplasties, Hip Replacement
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 25 Nov 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.
A Single-Center Randomized, Patient-Blinded, Prospective Five-Year Study to Compare the Functional Results after Insertion of ADM X3-MoP Cup (Stryker) and a CoC Cup (Zimmer) in Primary THA. 60 patients will be enrolled during a 2 year period. At surgery tantalum beads will be inserted into predrilled holes of the polyethylene rim for assessment of motion of the large mobile poly in the ADM Trident Cup by use of RSA. Patients will be followed by functional examinations as well as PROM assessment.
Detailed description
With Metal-on-Metal (MoM) articulations leaving the marked the THA bearing choice for younger patients is currently debated and overall the choice stands between CoC and MoP. New HXLPE is wear-resistant and safe and clinical HXLPE wear (RSA) hardly exceed the wear measured in retrieval CoC implants. For CoC articulations stripe wear on edge loading is a reported problem leading to increased wear in examined retrieval components and CoC wear is dependent on component position. Although the risk is very small, CoC bearings are at still at risk of fracture, and functional squeaking is a complication that adversely affects the quality of life in about 1% of CoC THA patient. Dual mobility MoP cups were designed for reducing hip dislocations in older patients treated with THA after medial hip fractures. The concept provides good stability and mobility and may also be an optimal solution for younger and active patients; however, dual mobility MoP has not previously been documented for use in younger patients. The anatomical dual mobility (ADM) cup design (Stryker) is soft tissue sparing (iliopsoas tendon) potentially leading to lesser groin-pain and squeaking is not a concern. It is currently unknown if the outer-articulation of the dual mobility PE liner keeps moving over time or could impinge in the joint capsule in an undesirable position and result in unwanted edge loading and higher wear-rates. Metal ions are produced even in MoP bearings and even though in dual-articulation MoP bearings most (90%) of the motion is believed to occur between the head and liner (ceramic-polyenthylene), the metal ion levels may be higher than expected for MoP hips (large poly contact in metal shell), while expectedly there will be no metal ions in CoC THA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADM X3-MoP Cup | Active comparator | Device: ADM X3-MoP CupTHA: ADM dual-mobility hydroxyapatite coated cups with X3TM HXLPE liners on 28mm BIOLOX® delta femoral heads (Stryker) with femoral stems being 2nd generation Accolade stems of the taper lock type, proximal circumferential coated with a 50µm plasma-spray PureFix HA coating to aid the mechanical engagement in bone coating (Stryker) |
| CoC Cup | Active comparator | Device: CoC CupTHA: CoC BIOLOX® delta-delta large-head single-mobility cementless fiber-mesh titanium coated acetabular system from Zimmer (Zimmer TrilogyIT cup/CLS spotorno stem) with a grit-blasted osteophilic titanium alloy CLS® Spotorno femoral stems (Zimmer) that has a three-dimensional wedge shape and sharpened ribs in the proximal region |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- primary hip osteoarthritis
- sufficient bone quality for total hip arthroplasty
- age 40 through 65 years of age
- informed and written consent
- patient can only enter the project with one hip
Key exclusion criteria (14 listed)
- neuromuscular or vascular disease in the affected leg
- patients with osteoporosis
- fracture sequelae or previous extensive hip surgery
- patients with metabolic bone disease including rheumatoid arthritis
- non-Danish citizenship
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 |
|---|---|---|
| ADM X3-MoP Cup | Device | ADM X3-MoP Cup |
| CoC Cup | Device | CoC Cup |
Primary outcome
Motion analysis (accelerometer (Ax3 Axivity) based activity monitoring)
Time frame: 5 year
For all participants: Inertia sensors are a new technology for patient motion analysis which allows simple and fast routine clinical movement analysis and long-term activity monitoring. We will employ the newest generation of accelerometer (Ax3 Axivity) based activity monitoring (small, light, low cost, validated for orthopaedic patients also with walking aids) to count, in real life, the number of events and the duration of postures and activities. Further muscle power investigations such as by use of the legg extension power rig will be used.
questionnaires ("the Harris Hip Score" (HHS), the Oxford Hip Score (OHS), the HOOS score, satisfaction, dislocation, and revisions)
Time frame: 5 year
For all participants: Pre- and postoperative clinical evaluations will be made according to "the Harris Hip Score" (HHS), the Oxford Hip Score (OHS), the HOOS score, and satisfaction, dislocations and revisions will be noted. Moreover, pre-operative rest and motion pains will be assessed by visual analogue scale scores (VAS).
Radiography (implant migration and wear)
Time frame: 5 year
For all participants: Within a week following surgery a stereo x-ray is performed and this functions as the baseline for future follow-up (in this study at 1 year, 2 years and 5 years). When comparing all stereo x-rays in a patient series, implant migration with respect to a set of bone markers can be calculated in three dimensions as a function of time - similarly wear of the implant surfaces can be evaluated.Fluoroscopic stereoradiometric recordings (Dynamic RSA) can be used to assess the functional motion of implants at desired motion speeds. In this study we record the liner motion of the ADM cup with the patients in different positions that in theory stresses the motion of the liner into new positions at edge-motions. The purpose is to gain knowledge on the safety function of the implant in vivo - if the liner moves and if it positions safely like it is supposed to.
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 6 Nov 2026.
- Derived from this study: PubMed 34907467Jorgensen PB, Kaptein BL, Soballe K, Jakobsen SS, Stilling M. Combined and hybrid marker models for radiostereometry assessment of polyethylene liner motion in dual mobility hip prosthesis: a proof-of-concept study. Eur Radiol Exp. 2021 Dec 15;5(1):55. doi: 10.1186/s41747-021-00253-x.
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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.
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 ADM X3-MoP Cup and CoC Cup in people with Arthroplasties, Hip Replacement, run by University of Aarhus 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 5 inclusion and 14 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: enrolling by invitation, as of the sponsor's last update on 6 Nov 2026. 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?
Motion analysis (accelerometer (Ax3 Axivity) based activity monitoring) (time frame: 5 year). The study lists 3 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 NCT02301182, 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 6 Nov 2026.