Migration in Total Hip Arthroplasty with a Cemented BiMobile Cup: Better Stability with More Cement?
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorJointResearch
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
BiMobile standard cement
Procedure/SurgeryBiMobile dual mobility cup, in a standard size after optimal reaming, resulting in a cement mantle of approximately 2mm.
BiMobile larger cement
Procedure/SurgeryBiMobile dual mobility cup, in one size smaller than standard after optimal reaming, resulting in a cement mantle of approximately 4mm.
Avantage standard cement
Procedure/SurgeryAvantage dual mobility cup, in a standard size after optimal reaming, resulting in a cement mantle of approximately 2mm.
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: BiMobile standard cementActive comparator 1 intervention
Group B: BiMobile larger cementActive comparator 1 intervention
Group C: Avantage standard cementActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Migration of the acetabular cup
Migration of the acetabular cup, measured with rontgen stereophotogrammetry analysis (RSA).
Time frame
2 years postoperativeSecondary outcomes
1
Migration of the acetabular cup
Migration of the acetabular cup, measured with rontgen stereophotogrammetry analysis (RSA).
Time frame
6 weeks, 6 months and 1 year postoperative2
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).
Time frame
prior to surgery, 6 months, 1 year, 2 years and 5 years after surgery3
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.
Time frame
prior to surgery, 6 months, 1 year, 2 years and 5 years after surgery4
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.
Time frame
prior to surgery, 6 months, 1 year, 2 years and 5 years after surgerySponsors and contacts
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Source ClinicalTrials.gov