NCT04049279 Migration in Total Hip Arthroplasty with a Cemented BiMobile Cup: Better Stability with More Cement?
| NCT ID | NCT04049279 |
| Status | Recruiting |
| Phase | — |
| Sponsor | JointResearch |
| Condition | Total Hip Arthroplasty |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2019-01-01 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 75 participants in total. It began in 2019-01-01 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Rudolf Poolman, MD, PhD
PRINCIPAL INVESTIGATOR
OLVG
Frequently Asked Questions
Who can join the NCT04049279 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Total Hip Arthroplasty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04049279 currently recruiting?
Yes, NCT04049279 is actively recruiting participants. Contact the research team at l.w.a.h.vanbeers@olvg.nl for enrollment information.
Where is the NCT04049279 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT04049279 clinical trial?
NCT04049279 is sponsored by JointResearch. The principal investigator is Rudolf Poolman, MD, PhD at OLVG. The trial plans to enroll 75 participants.