Total Hip ArthroplastyBe-MobileNCT04049279
Migration in Total Hip Arthroplasty with a Cemented BiMobile Cup: Better Stability with More Cement?
A study testing BiMobile standard cement, BiMobile larger cement and Avantage standard cement in people with Total Hip Arthroplasty and Osteoarthritis, Hip, run by JointResearch at 1 site in Netherlands.
Trial summary
Objective: The main objective of this study is to compare the (early) migration of the cemented BiMobile cup at two year post-surgery between two different cup sizes after standard optimal reaming, and consequently adjusting the cement mantle into circa 2 or 4 mm, in patients with a primary cemented total hip… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Total Hip Arthroplasty, Osteoarthritis, Hip
- What is being tested?
- BiMobile standard cement, BiMobile larger cement and Avantage standard cement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2019to 1 May 2029
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient requiring an elective primary cemented THA.
- Male patient ≥70 years old and female patient ≥65 years old.
- Ability and willingness to follow instructions and to return for follow-up evaluations.
- The patient is able to understand the meaning of the study and is willing to sign informed consent.
- Understanding the Dutch language.
Who cannot join
- The patient is morbidly obese, defined as Body Mass Index (BMI) of ≥ 40.
- The patient is expected to need lower limb joint replacement for another joint within one year.
- The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
- The patient has a deformity or disease located in other joints than the hip that needs surgery and that is limiting their ability to walk.
- The patient has an active or suspected latent infection in or around the hip joint.
- The patient's bone stock is compromised by a disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
- The patient is unable or unwilling to sign informed consent for this study.
- The patient is deemed unsuitable for participation in the study based on the investigator's judgment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
OLVG
Amsterdam, 1091 AC
Loes van Beers, MSc, +31(0)20-5993653, l.w.a.h.vanbeers@olvg.nl
Nienke Willigenburg, PhD, +31(0)20-5992415, n.w.willigenburg@olvg.nl
About this study
Official title: Migration in Total Hip Arthroplasty with a Cemented BiMobile Cup: Better Stability with More Cement? (Be-Mobile)
Objective: The main objective of this study is to compare the (early) migration of the cemented BiMobile cup at two year post-surgery between two different cup sizes after standard optimal reaming, and consequently adjusting the cement mantle into circa 2 or 4 mm, in patients with a primary cemented total hip arthroplasty (THA). Additionally, the results of the BiMobile cup will be compared to the Avantage cup, which is placed with a standard cup size, resulting in a cement mantle of approximately 2 mm.
Study design: A prospective single centre blinded randomised controlled trial.
Study population: All patients who meet the criteria to undergo a cemented THA.
Read the detailed description
Rationale: Total hip arthroplasty (THA) is a commonly performed surgery in patients with end-stage osteoarthritis (OA) of the hip. Although it is known as a successful procedure, (recurrent) dislocation after THA is a major problem and results in a deterioration in quality of life. Dislocation after THA is the number one cause of early revision surgery.
Dual-Mobility (DM) acetabular cups should provide more stability and biomechanically reduce the risk of (early) dislocation. Potential disadvantages of DM cups are increased liner wear, psoas impingement and loosening. This might result in more revision surgery at mid- and longer-term follow-up for the cemented cups. If the cemented fixation technique improves, this might diminish the disadvantages of more revisions due to loosening in cemented cups. High quality evidence guiding the best technique for cemented fixation is however lacking. The risk of implant loosening might be reduced by increasing the amount of cement used for cup fixation. It is currently unknown whether size of the implant, and thereby the amount of cement, affects stability and survival. To fill this gap in knowledge, this study will compare cup migration, as an indicator for loosening, in a new dual mobility cup (BiMobile, Waldemar Link GmbH \& Co. KG, Hamburg, Germany), using a larger or smaller cup size (and thereby different amounts of cement: approximately 2mm or 4mm cement mantle). These results will also be compared with the Avantage cup (ZimmerBiomet), which is yet considered as a standard dual mobility cup in the Netherlands. Migration will be measured with Rontgen Stereophotogrammetry Analysis (RSA), which is currently the gold standard for measuring early migration and predicting long term survival. A relatively new and less intensive way to measure migration of prostheses is the use of computer tomography (CT) scans, however there is still little scientific evidence on how accurately this can be done. This study therefore also measures the accuracy with which migration is measured, between CT scans and RSA.
Objective: The main objective of this study is to compare the (early) migration of the cemented BiMobile cup at two year post-surgery between two different cup sizes after standard optimal reaming, and consequently adjusting the cement mantle into circa 2 or 4 mm, in patients with a primary cemented THA. Additionally, the results of the BiMobile cup will be compared to the Avantage cup, which is placed with a standard cup size, resulting in a cement mantle of approximately 2 mm.
Study design: A prospective single centre blinded randomised controlled trial.
Study population: At the outpatient clinic of OLVG, all patients who meet the criteria to undergo a cemented THA will be screened for the in- and exclusion criteria.
Intervention:
Group A: 25 patients will receive a cemented THA with a BiMobile dual mobility cup, in a standard size after optimal reaming, resulting in a cement mantle of approximately 2mm.
Group B: 25 patients will receive a cemented THA with a BiMobile dual mobility cup, in one size smaller than standard after optimal reaming, resulting in a cement mantle of approximately 4mm.
Group C: 25 patients will receive a cemented THA with an Avantage dual mobility cup, in a standard size after optimal reaming, resulting in a cement mantle of approximately 2mm.
Main study parameters/endpoints:
Migration of the acetabular cup at two year postoperative, measured with RSA and CT. RSA x-rays will be collected at discharge, 6 weeks, 6 months, 1 year and 2 years after surgery. CT scans will be collected at discharge and 2 years after surgery.
- Conditions
- Total Hip Arthroplasty, Osteoarthritis, Hip
- Being tested
- BiMobile standard cement, BiMobile larger cement, Avantage standard cement
- Keywords
- primary total hip arthroplasty, RSA, cement, Dual mobility cup
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiMobile standard cementProcedure or surgery
BiMobile dual mobility cup, in a standard size after optimal reaming, resulting in a cement mantle of approximately 2mm.
BiMobile larger cementProcedure or surgery
BiMobile dual mobility cup, in one size smaller than standard after optimal reaming, resulting in a cement mantle of approximately 4mm.
Avantage standard cementProcedure or surgery
Avantage dual mobility cup, in a standard size after optimal reaming, resulting in a cement mantle of approximately 2mm.
| Study group | Role | What they receive |
|---|---|---|
| BiMobile standard cement | Active comparator | 25 patients will receive a cemented THA with a BiMobile dual mobility cup, in a standard size after optimal reaming, resulting in a cement mantle of approximately 2mm. Receives: Procedure: BiMobile standard cement |
| BiMobile larger cement | Active comparator | 25 patients will receive a cemented THA with a BiMobile dual mobility cup, in one size smaller than standard after optimal reaming, resulting in a cement mantle of approximately 4mm. Receives: Procedure: BiMobile larger cement |
| Avantage standard cement | Active comparator | 25 patients will receive a cemented THA with an Avantage dual mobility cup, in a standard size after optimal reaming, resulting in a cement mantle of approximately 2mm. Receives: Procedure: Avantage standard cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migration of the acetabular cup
Migration of the acetabular cup, measured with rontgen stereophotogrammetry analysis (RSA).
Measured: 2 years postoperative
Secondary outcomes (5)
Migration of the acetabular cup
Migration of the acetabular cup, measured with rontgen stereophotogrammetry analysis (RSA).
Measured: 6 weeks, 6 months and 1 year postoperative
Patient reported outcomes on physical functioning
Difference in patient reported outcomes on physical functioning following primary THA with a BiMobile cup with 2mm cement, compared to the BiMobile cup with 4mm cement and the Avantage cup, measured with the Hip disability and Osteoarthritis Outcome Score Physical Short form (HOOS-PS). Interval level scores from 0 (no difficulty) to 100 (extreme difficulty).
Measured: prior to surgery, 6 months, 1 year, 2 years and 5 years after surgery
Patient reported outcomes on quality of life.
Difference in patient reported outcomes on quality of life, following primary THA with a BiMobile cup with 2mm cement, compared to the BiMobile cup with 4mm cement and the Avantage cup, measured with the EuroQol 5 Dimensions (EQ-5D). A higher score means a worse quality of life, a lower score means a better quality of life. For the visual analogue scale (part of the EQ-5D), the lowest means the worst an the highest score means the best health score.
Measured: prior to surgery, 6 months, 1 year, 2 years and 5 years after surgery
Patient reported outcomes on pain
Difference in patient reported outcomes on pain, following primary THA with a BiMobile cup with 2mm cement, compared to the BiMobile cup with 4mm cement and the Avantage cup, measured with the Numeric Ratin Scale (NRS) for pain in rest and during weight bearing. 0 means no pain, 10 means the most extreme pain.
Measured: prior to surgery, 6 months, 1 year, 2 years and 5 years after surgery
Patient Satisfaction
patient satisfaction will be scored with an anchor question about general daily functioning.
Measured: prior to surgery, 6 months, 1 year, 2 years and 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start1 Jan 2019
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JointResearch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rudolf Poolman, MD, PhD, Principal investigator, OLVG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049279
- Sponsor's protocol ID
- NL64196.100.17
- Acronym
- Be-Mobile
- Status last verified
- Feb 2025
- First submitted
- 4 Jul 2019
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Migration in Total Hip Arthroplasty with a Cemented BiMobile Cup: Better Stability with More Cement? (Be-Mobile)
- ClinicalTrials.gov ID
- NCT04049279
- Acronym / sponsor ID
- Be-Mobile / NL64196.100.17
- Conditions
- Total Hip Arthroplasty, Osteoarthritis, Hip
- Keywords
- primary total hip arthroplasty, RSA, cement, Dual mobility cup
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- JointResearchUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 8 Aug 2019 (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.
Objective: The main objective of this study is to compare the (early) migration of the cemented BiMobile cup at two year post-surgery between two different cup sizes after standard optimal reaming, and consequently adjusting the cement mantle into circa 2 or 4 mm, in patients with a primary cemented total hip arthroplasty (THA). Additionally, the results of the BiMobile cup will be compared to the Avantage cup, which is placed with a standard cup size, resulting in a cement mantle of approximately 2 mm.
Study design: A prospective single centre blinded randomised controlled trial.
Study population: All patients who meet the criteria to undergo a cemented THA.
Detailed description
Rationale: Total hip arthroplasty (THA) is a commonly performed surgery in patients with end-stage osteoarthritis (OA) of the hip. Although it is known as a successful procedure, (recurrent) dislocation after THA is a major problem and results in a deterioration in quality of life. Dislocation after THA is the number one cause of early revision surgery.
Dual-Mobility (DM) acetabular cups should provide more stability and biomechanically reduce the risk of (early) dislocation. Potential disadvantages of DM cups are increased liner wear, psoas impingement and loosening. This might result in more revision surgery at mid- and longer-term follow-up for the cemented cups. If the cemented fixation technique improves, this might diminish the disadvantages of more revisions due to loosening in cemented cups. High quality evidence guiding the best technique for cemented fixation is however lacking. The risk of implant loosening might be reduced by increasing the amount of cement used for cup fixation. It is currently unknown whether size of the implant, and thereby the amount of cement, affects stability and survival. To fill this gap in knowledge, this study will compare cup migration, as an indicator for loosening, in a new dual mobility cup (BiMobile, Waldemar Link GmbH \& Co. KG, Hamburg, Germany), using a larger or smaller cup size (and thereby different amounts of cement: approximately 2mm or 4mm cement mantle). These results will also be compared with the Avantage cup (ZimmerBiomet), which is yet considered as a standard dual mobility cup in the Netherlands. Migration will be measured with Rontgen Stereophotogrammetry Analysis (RSA), which is currently the gold standard for measuring early migration and predicting long term survival. A relatively new and less intensive way to measure migration of prostheses is the use of computer tomography (CT) scans, however there is still little scientific evidence on how accurately this can be done. This study therefore also measures the accuracy with which migration is measured, between CT scans and RSA.
Objective: The main objective of this study is to compare the (early) migration of the cemented BiMobile cup at two year post-surgery between two different cup sizes after standard optimal reaming, and consequently adjusting the cement mantle into circa 2 or 4 mm, in patients with a primary cemented THA. Additionally, the results of the BiMobile cup will be compared to the Avantage cup, which is placed with a standard cup size, resulting in a cement mantle of approximately 2 mm.
Study design: A prospective single centre blinded randomised controlled trial.
Study population: At the outpatient clinic of OLVG, all patients who meet the criteria to undergo a cemented THA will be screened for the in- and exclusion criteria.
Intervention:
Group A: 25 patients will receive a cemented THA with a BiMobile dual mobility cup, in a standard size after optimal reaming, resulting in a cement mantle of approximately 2mm.
Group B: 25 patients will receive a cemented THA with a BiMobile dual mobility cup, in one size smaller than standard after optimal reaming, resulting in a cement mantle of approximately 4mm.
Group C: 25 patients will receive a cemented THA with an Avantage dual mobility cup, in a standard size after optimal reaming, resulting in a cement mantle of approximately 2mm.
Main study parameters/endpoints:
Migration of the acetabular cup at two year postoperative, measured with RSA and CT. RSA x-rays will be collected at discharge, 6 weeks, 6 months, 1 year and 2 years after surgery. CT scans will be collected at discharge and 2 years after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BiMobile standard cement | Active comparator | Procedure: BiMobile standard cement25 patients will receive a cemented THA with a BiMobile dual mobility cup, in a standard size after optimal reaming, resulting in a cement mantle of approximately 2mm. |
| BiMobile larger cement | Active comparator | Procedure: BiMobile larger cement25 patients will receive a cemented THA with a BiMobile dual mobility cup, in one size smaller than standard after optimal reaming, resulting in a cement mantle of approximately 4mm. |
| Avantage standard cement | Active comparator | Procedure: Avantage standard cement25 patients will receive a cemented THA with an Avantage dual mobility cup, in a standard size after optimal reaming, resulting in a cement mantle of approximately 2mm. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patient requiring an elective primary cemented THA.
- Male patient ≥70 years old and female patient ≥65 years old.
- Ability and willingness to follow instructions and to return for follow-up evaluations.
- The patient is able to understand the meaning of the study and is willing to sign informed consent.
- Understanding the Dutch language.
Key exclusion criteria (8 listed)
- The patient is morbidly obese, defined as Body Mass Index (BMI) of ≥ 40.
- The patient is expected to need lower limb joint replacement for another joint within one year.
- The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
- The patient has a deformity or disease located in other joints than the hip that needs surgery and that is limiting their ability to walk.
- The patient has an active or suspected latent infection in or around the hip joint.
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 |
|---|---|---|
| BiMobile standard cementBiMobile dual mobility cup, in a standard size after optimal reaming, resulting in a cement mantle of approximately 2mm. | Procedure or surgery | BiMobile standard cement |
| BiMobile larger cementBiMobile dual mobility cup, in one size smaller than standard after optimal reaming, resulting in a cement mantle of approximately 4mm. | Procedure or surgery | BiMobile larger cement |
| Avantage standard cementAvantage dual mobility cup, in a standard size after optimal reaming, resulting in a cement mantle of approximately 2mm. | Procedure or surgery | Avantage standard cement |
Primary outcome
Migration of the acetabular cup
Time frame: 2 years postoperative
Migration of the acetabular cup, measured with rontgen stereophotogrammetry analysis (RSA).
5 secondary outcomes
Migration of the acetabular cup
Time frame: 6 weeks, 6 months and 1 year postoperative
Patient reported outcomes on physical functioning
Time frame: prior to surgery, 6 months, 1 year, 2 years and 5 years after surgery
Patient reported outcomes on quality of life.
Time frame: prior to surgery, 6 months, 1 year, 2 years and 5 years after surgery
Patient reported outcomes on pain
Time frame: prior to surgery, 6 months, 1 year, 2 years and 5 years after surgery
Patient Satisfaction
Time frame: prior to surgery, 6 months, 1 year, 2 years and 5 years after surgery
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 28 Feb 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.
Rudolf Poolman, MD, PhD principal investigator
OLVG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BiMobile standard cement, BiMobile larger cement and Avantage standard cement in people with Total Hip Arthroplasty and Osteoarthritis, Hip, run by JointResearch at 1 site in Netherlands.
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 8 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 28 Feb 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 Netherlands. 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 Loes van Beers, MSc (+31(0)20-5993653, l.w.a.h.vanbeers@olvg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migration of the acetabular cup (time frame: 2 years postoperative). 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 28 Feb 2025.