Migration in Total Hip Arthroplasty with a Cemented BiMobile Cup: Better Stability with More Cement? (Be-Mobile)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
OLVG
RECRUITING
Amsterdam
Contact Information
Primary
Loes van Beers, MSc
l.w.a.h.vanbeers@olvg.nl
+31(0)20-5993653
Backup
Nienk Willigenburg, PhD
n.w.willigenburg@olvg.nl
+31(0)20-5992415
Time Frame
Start Date: 2019-01-01
Estimated Completion Date: 2029-05-01
Participants
Target number of participants: 75
Treatments
Active_comparator: BiMobile standard cement
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.
Active_comparator: BiMobile larger cement
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.
Active_comparator: Avantage standard cement
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.
Sponsors
Leads: JointResearch

This content was sourced from clinicaltrials.gov