Coxarthrosis; PrimaryCeMoD-primeNCT05547984
Ceramic Modular Dual Mobility in Primary Total Hip Arthroplasty (THA)
A study testing Dual Mobility Cup and Standard Acetabular component in people with Coxarthrosis; Primary, run by Aesculap AG at 1 site in Czechia.
Trial summary
A randomized controlled trial comparing modular dual mobility inserts with ceramic multilayer coating versus standard polyethylene inserts for primary THA in a cementless acetabular cup Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coxarthrosis; Primary
- What is being tested?
- Dual Mobility Cup and Standard Acetabular component
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 21 Nov 2022to Aug 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary coxarthrosis patients indicated for cementless total hip arthroplasty
- Written informed patient consent
Who cannot join
- Hip trauma or revision surgery
- Rheumatoid or neurologic disease
- BMI >35
- Ongoing oncologic therapy
- Preoperatively elevated Co or Cr serum levels >1.0 µg/L
- Patients with other joint implants, or anticipated need for another joint replacement surgery within the study period
Show all 10Show fewer
- Acetabular cup size <52 expected
- Patients not able to mentally or physically comply with the study demands and follow-up visits
- Patients <18 years at surgery
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Masaryk Hospital
Ústí nad Labem
Tomas Novotny, MuDr.
About this study
Official title: A Randomized Controlled Trial Comparing Modular Dual Mobility Inserts With Ceramic Multilayer Coating Versus Standard Polyethylene Inserts for Primary Total Hip Arthroplasty (THA) in a Cementless Acetabular Cup
A randomized controlled trial comparing modular dual mobility inserts with ceramic multilayer coating versus standard polyethylene inserts for primary THA in a cementless acetabular cup
Read the detailed description
The aim of this study is to show in a randomized controlled trial that cobalt and chromium ion serum levels are comparable to the metal ion levels in patients with standard articulation with metal head. The metal on polyethylene articulation is accepted as standard articulation since many decades, and which is currently in the Czech Republic the most used combination. Most studies which focused on the topic of metal ion release from modular dual mobility systems do not present results of a control group with standard articulation hip implants.
- Conditions
- Coxarthrosis; Primary
- Being tested
- Dual Mobility Cup, Standard Acetabular component
- Keywords
- Dual Mobility Cup, Total Hip Arthroplasty
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Mobility CupDevice
Also called Total Hip Arthroplasty
Total hip arthroplasty (THA) is a successful and established therapy for coxarthrosis, rheumatic arthritis, hip fractures and femoral head necrosis. The acetabular implant for this arm is the Dual Mobility cup
Standard Acetabular componentDevice
Also called Total Hip Arthroplasty
Total hip arthroplasty (THA) is a successful and established therapy for coxarthrosis, rheumatic arthritis, hip fractures and femoral head necrosis. The acetabular implant for this arm is the standard device with polyethylene + vitamin E inlay and metal head
| Study group | Role | What they receive |
|---|---|---|
| Dual Mobility Cup | Experimental | dual mobility articulation Receives: Device: Dual Mobility Cup |
| Standard Acetabular component | Active comparator | standard articulation with polyethylene + vitamin E inlay and metal head Receives: Device: Standard Acetabular component |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum metal ion analysis (Cobalt)
Cobalt ion levels in blood serum in measured in [µg/L], Comparison between the two groups
Measured: 12 months after surgery
Serum metal ion analysis (Chromium)
Chromium ion levels in blood serum in measured in [µg/L], Comparison between the two groups
Measured: 12 months after surgery
Secondary outcomes (7)
Change of functional outcome over three year follow-up period (Harris Hip Score)
The Harris Hip Score (HHS) is one of the most used scores in total hip arthroplasty, mainly combining range of motion questions with questions regarding daily life activities. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. Results can be recorded and calculated online. The maximum score possible is 100, any result <70 is considered a poor result; The HHS is an outcome measure administered by a qualified health care professional, such as a physician or a physical therapist.
Measured: 3 months, 12 months and 3 years postoperatively
Gait analysis over time
The gait lab analysis involves a high amount of recorded data and variables. Gait lab analyses are performed with the patients between the preoperative state, 3 months after surgery and 1 year postoperative. The Gait Profile Score (GPS) is used as a measure for the deviation in gait kinematics from a healthy patient population to compare the two treatment groups.
Lower score values can be considered as a sign of better restoration of the physiological gait kinematics.
Measured: preoperative, 3 months and 12 months postoperatively
Development of Patient satisfaction with surgery result over time
Patient is asked for satisfaction with surgery result with a 4-point scale: very satisfied, satisfied, unsatisfied, very unsatisfied
Measured: at three examinations during Follow-Up (3 months postop, 1 year postop, 3 years postop)
Radiologic Evaluation: Cup Inclination over time
Inclination is the orientation of the cup in the coronal plane. The target acetabular cup inclination is a "safe zone" between 30-50° abduction (assessed on antero-posterior (ap) x-rays of the hip). The comparison of the intraoperatively achieved inclination and the inclination at different follow-up examinations allows prediction on longterm success.
Measured: immediately postoperative, 3 months, 12 months and 3 years postoperative
Radiologic Evaluation: center of rotation
Centre of Rotation (CoR) is defined as the zero position for the measurement of potential cup migration. Horizontal: Distance of CoR to ipsilateral teardrop; Vertical: Distance CoR to Inter-teardrop line; The comparison of the intraoperatively center of rotation and the center of rotation at different follow-up examinations allows prediction on longterm success.
Measured: immediately postoperative, 3 months, 12 months and 3 years postoperative
Radiologic Evaluation: Radiolucencies around the cup
Bony Osseointegration or conspicuous features of the cup are assessed on anterior-posterior and lateral x-rays of the cup and will be analysed according to the zones defined by Charnley. "Charnley" zones of the acetabular component are distinct zones used in assessment of aseptic loosening in total hip joint replacements. The radiolucencies are categorized to "none", "less than or equal to 2mm" and "more than 2 mm"
Measured: over follow-up period 3 months, 12 months and 3 years postoperative
Radiological Outcome: Heterotopic Ossification
Brooker classification divides heterotopic ossifications that form following total hip replacement to four classes. Class I: islands of bone within soft tissues around hip; Class II: bone spurs in pelvis or proximal end of femur leaving ≥1 cm between the opposing bone surfaces; Class III: bone spurs that extend from pelvis or the proximal end of femur, which reduce the space between the opposing bone surfaces to <1cm; Class IV: ankylosis of the hip on x-ray
Measured: over follow-up period 3 months, 12 months and 3 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start21 Nov 2022
- Primary completionSep 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coxarthrosis; PrimaryStudies 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547984
- Sponsor's protocol ID
- AAG-G-H-2203
- Acronym
- CeMoD-prime
- Status last verified
- Dec 2025
- First submitted
- 16 Sep 2022
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Modular Dual Mobility Inserts With Ceramic Multilayer Coating Versus Standard Polyethylene Inserts for Primary Total Hip Arthroplasty (THA) in a Cementless Acetabular Cup
- ClinicalTrials.gov ID
- NCT05547984
- Acronym / sponsor ID
- CeMoD-prime / AAG-G-H-2203
- Conditions
- Coxarthrosis; Primary
- Keywords
- Dual Mobility Cup, Total Hip Arthroplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 21 Sep 2022 (actual)
- 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 randomized controlled trial comparing modular dual mobility inserts with ceramic multilayer coating versus standard polyethylene inserts for primary THA in a cementless acetabular cup
Detailed description
The aim of this study is to show in a randomized controlled trial that cobalt and chromium ion serum levels are comparable to the metal ion levels in patients with standard articulation with metal head. The metal on polyethylene articulation is accepted as standard articulation since many decades, and which is currently in the Czech Republic the most used combination. Most studies which focused on the topic of metal ion release from modular dual mobility systems do not present results of a control group with standard articulation hip implants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual Mobility Cup | Experimental | Device: Dual Mobility Cupdual mobility articulation |
| Standard Acetabular component | Active comparator | Device: Standard Acetabular componentstandard articulation with polyethylene + vitamin E inlay and metal head |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary coxarthrosis patients indicated for cementless total hip arthroplasty
- Written informed patient consent
Key exclusion criteria (10 listed)
- Hip trauma or revision surgery
- Rheumatoid or neurologic disease
- BMI >35
- Ongoing oncologic therapy
- Preoperatively elevated Co or Cr serum levels >1.0 µg/L
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 |
|---|---|---|
| Dual Mobility CupAlso: Total Hip ArthroplastyTotal hip arthroplasty (THA) is a successful and established therapy for coxarthrosis, rheumatic arthritis, hip fractures and femoral head necrosis. The acetabular implant for this arm is the Dual Mobility cup | Device | Dual Mobility Cup |
| Standard Acetabular componentAlso: Total Hip ArthroplastyTotal hip arthroplasty (THA) is a successful and established therapy for coxarthrosis, rheumatic arthritis, hip fractures and femoral head necrosis. The acetabular implant for this arm is the standard device with polyethylene + vitamin E inlay and metal head | Device | Standard Acetabular component |
Primary outcome
Serum metal ion analysis (Cobalt)
Time frame: 12 months after surgery
Cobalt ion levels in blood serum in measured in [µg/L], Comparison between the two groups
Serum metal ion analysis (Chromium)
Time frame: 12 months after surgery
Chromium ion levels in blood serum in measured in [µg/L], Comparison between the two groups
7 secondary outcomes
Change of functional outcome over three year follow-up period (Harris Hip Score)
Time frame: 3 months, 12 months and 3 years postoperatively
Gait analysis over time
Time frame: preoperative, 3 months and 12 months postoperatively
Development of Patient satisfaction with surgery result over time
Time frame: at three examinations during Follow-Up (3 months postop, 1 year postop, 3 years postop)
Radiologic Evaluation: Cup Inclination over time
Time frame: immediately postoperative, 3 months, 12 months and 3 years postoperative
Radiologic Evaluation: center of rotation
Time frame: immediately postoperative, 3 months, 12 months and 3 years postoperative
Radiologic Evaluation: Radiolucencies around the cup
Time frame: over follow-up period 3 months, 12 months and 3 years postoperative
Radiological Outcome: Heterotopic Ossification
Time frame: over follow-up period 3 months, 12 months and 3 years postoperative
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 16 Dec 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual Mobility Cup and Standard Acetabular component in people with Coxarthrosis; Primary, run by Aesculap AG at 1 site in Czechia.
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 10 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: looking for participants now, as of the sponsor's last update on 16 Dec 2025. 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 Czechia. 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?
Contact Lutz Dreyer, Dr. (+49746195, info@aesculap.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum metal ion analysis (Cobalt) (time frame: 12 months after surgery). The study lists 2 primary outcomes in all. 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 16 Dec 2025.